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FDA 510(k)

CONVEEN URINE BAG - STERILE

K-Number: K955609 · 1995-12-29

ApplicantColoplast Corp.
Decision Date1995-12-29
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONVEEN URINE BAG - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1995-12-29 under 510(k) number K955609. 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 CONVEEN URINE BAG - STERILE?

CONVEEN URINE BAG - STERILE is a medical device that received FDA 510(k) clearance on 1995-12-29. The listed applicant is Coloplast Corp.. The 510(k) number is K955609.

When did CONVEEN URINE BAG - STERILE receive FDA 510(k) clearance?

CONVEEN URINE BAG - STERILE received FDA 510(k) clearance on 1995-12-29, under 510(k) number K955609.

Who is the listed applicant for CONVEEN URINE BAG - STERILE?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONVEEN URINE BAG - STERILE?

The FDA product code for CONVEEN URINE BAG - STERILE is FAQ.

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Other records listing Coloplast Corp. as applicant

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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 ReliabilityK953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & SonsK953783CONVEEN LEG BAG STRAPColoplast Corp.K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & SonsK945204URINE 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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