James River Corp.
Walker, MI, US
James River Corp. appears in FDA device records in Walker, MI. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for James River Corp. between 1983 and 1989. The busiest year on record is 1988, with 6. The most recent is 1989, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1986 | 2 |
| 1988 | 6 |
| 1989 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K894505 | COTOLIN DRAIN SPONGE AND DRESSING SPONGE | EFQ | Substantially Equivalent | |
| K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING | KGX | Substantially Equivalent for Some Indications | |
| K894034 | MODIFIED LABELING OF SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K893939 | ISOLATION MASKS | FXX | Substantially Equivalent | |
| K892580 | CARETOUCH EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K890459 | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K883802 | CARETEX CENTRAL SUPPLY WRAP | FRG | Substantially Equivalent | |
| K884112 | CARETEX OR TOWEL | KKX | Substantially Equivalent | |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | FXP | Substantially Equivalent | |
| K880481 | CARETEX SURGEON'S CAPS | FYF | Substantially Equivalent | |
| K880431 | CARETEX SURGEON'S HOODS | FXY | Substantially Equivalent | |
| K880093 | CARETEX SKID RESISTANT SHOE COVERS | FXP | Substantially Equivalent | |
| K864550 | CARETEX SHOE COVERS | FXP | Substantially Equivalent | |
| K864479 | CARETEX ISOLUTION GOWNS | FYC | Substantially Equivalent | |
| K823513 | CENTRAL SUPPLY ROOM WRAP | FRG | 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 James River Corp. 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 James River Corp.. 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