510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Custom Pack Reliability

Orlando, FL, US

Custom Pack Reliability appears in FDA device records in Orlando, FL. FDA records list 21 510(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
21
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 21 510(k) clearances for Custom Pack Reliability in 1996.

Clearances by year, as a table
510(k) clearance decisions for Custom Pack Reliability, by decision year
YearClearances
199621
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K960205CPR TRACHEOTOMY CARE TRAYBTOSubstantially Equivalent
K960243CPR C-SECTION DELIVERY PACKMLSSubstantially Equivalent
K960239CPR D & C TRAYHHKSubstantially Equivalent
K960216CPR SUCTION CATHETER KITJOLSubstantially Equivalent
K960213CPR TOTAL HIP PACKFRGSubstantially Equivalent
K960211CPR TOTAL KNEE PACKFRGSubstantially Equivalent
K960210CPR ORTHO HAND PACKFRGSubstantially Equivalent
K960206CPR DRESSING CHANGE TRAYFRGSubstantially Equivalent
K960209CPR HEART PACKGAWSubstantially Equivalent
K960215CPR URETHRAL CATHETER TRAYFCMSubstantially Equivalent
K960214CPR FOLEY CAHTETER KITFCMSubstantially Equivalent
K960212CPR IRRIGATION TRAYKYZSubstantially Equivalent
K960238CPR SUTURE REMOVAL KITFRGSubstantially Equivalent
K960236CPR LAP SPONGESGDYSubstantially Equivalent
K960223CPR YANKAUERGCXSubstantially Equivalent
K960218CONNECTING TUBINGBYYSubstantially Equivalent
K960217CPR URINE BAGFAQSubstantially Equivalent
K960208CPR BASIC SET-UP TRAYFRGSubstantially Equivalent
K960241CPR GENERAL SURGERY TRAYLWISubstantially Equivalent
K960242CPR EYE TRAYKKXSubstantially Equivalent
K960207CPR LACERATION TRAYFRGSubstantially 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.

What MDM checks, and what it does not

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 Custom Pack Reliability 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 Custom Pack Reliability. 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