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FDA 510(k)

CONVEEN(R) LEG BAG(500 ML)

K-Number: K924406 · 1992-10-30

ApplicantColoplast A/S
Decision Date1992-10-30
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONVEEN(R) LEG BAG(500 ML) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1992-10-30 under 510(k) number K924406. 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(R) LEG BAG(500 ML)?

CONVEEN(R) LEG BAG(500 ML) is a medical device that received FDA 510(k) clearance on 1992-10-30. The listed applicant is Coloplast A/S. The 510(k) number is K924406.

When did CONVEEN(R) LEG BAG(500 ML) receive FDA 510(k) clearance?

CONVEEN(R) LEG BAG(500 ML) received FDA 510(k) clearance on 1992-10-30, under 510(k) number K924406.

Who is the listed applicant for CONVEEN(R) LEG BAG(500 ML)?

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

What is the FDA product code for CONVEEN(R) LEG BAG(500 ML)?

The FDA product code for CONVEEN(R) LEG BAG(500 ML) is FAQ.

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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.K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons

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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