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FDA 510(k)

PROSYS LEG BAG

K-Number: K951945 · 1995-05-25

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1995-05-25
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROSYS LEG BAG is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1995-05-25 under 510(k) number K951945. The device is classified under product code FAQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSYS LEG BAG?

PROSYS LEG BAG is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K951945.

When did PROSYS LEG BAG receive FDA 510(k) clearance?

PROSYS LEG BAG received FDA 510(k) clearance on 1995-05-25, under 510(k) number K951945.

Who is the listed applicant for PROSYS LEG BAG?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSYS LEG BAG?

The FDA product code for PROSYS LEG BAG is FAQ.

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Other records listing Convatec, A Division of E.R. Squibb & Sons as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: FAQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962604PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & SonsK960217CPR URINE BAGCustom Pack ReliabilityK955609CONVEEN URINE BAG - STERILEColoplast Corp.K953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & SonsK953783CONVEEN LEG BAG STRAPColoplast Corp.K945204URINE COLLECTOR & ACCESSORIESNelmed Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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