Fraass Survival Systems, Inc.
Walker, MI, US
Fraass Survival Systems, Inc. appears in FDA device records in Walker, MI. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Fraass Survival Systems, Inc. between 1984 and 1991. The busiest year on record is 1987, with 14. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 7 |
| 1987 | 14 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | NAD | Substantially Equivalent | |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | KDD | Substantially Equivalent | |
| K871437 | SURVIVAL KIT, INDIVIDUAL | LRO | Substantially Equivalent | |
| K871434 | MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S | LRO | Substantially Equivalent | |
| K871917 | FRASTEC DRY GAUZE BANDAGE | EFQ | Substantially Equivalent for Some Indications | |
| K871916 | FRASTEC DRY BURN DRESSING | EFQ | Substantially Equivalent for Some Indications | |
| K871376 | FIRST AID KIT, VARIOUS SIZES | LRR | Unknown | |
| K871501 | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE | LRR | Substantially Equivalent | |
| K871457 | FIRST AID KIT, EYE DRESSING | LRR | Unknown | |
| K871438 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 | EFQ | Substantially Equivalent | |
| K870240 | COMPRESS AND SKULLCAP, HEAD DRESSING | EXR | Substantially Equivalent | |
| K870241 | COMPRESS AND BANDAGE, VARIOUS SIZES | FRO | Substantially Equivalent | |
| K870239 | DRESSING, BURN, 24 BY 36 INCHES | NAD | Substantially Equivalent | |
| K870185 | BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) | NAD | Substantially Equivalent | |
| K870184 | BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES | FRO | Substantially Equivalent | |
| K864011 | EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES | NAD | Substantially Equivalent for Some Indications | |
| K864023 | EYE PAD, COTTON, GAUZE COVERED | Substantially Equivalent | ||
| K864175 | SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES | EFQ | Substantially Equivalent | |
| K863932 | GAUZE, ABSORBENT, STERILE, COMPRESSED | EFQ | Substantially Equivalent | |
| K863850 | DRESSING, FIRST AID, FIELD, VARIOUS SIZES | EFQ | Substantially Equivalent | |
| K863714 | BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES | EFQ | Substantially Equivalent | |
| K863713 | BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES | EFQ | Substantially Equivalent | |
| K840498 | EXU-DRY BURN-TRAUMA DRESSING-VARIOUS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Fraass Survival Systems, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Fraass Survival Systems, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain