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FDA 510(k)

CONVEEN LEG BAG STRAP

K-Number: K953783 · 1995-09-13

ApplicantColoplast Corp.
Decision Date1995-09-13
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONVEEN LEG BAG STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1995-09-13 under 510(k) number K953783. 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 LEG BAG STRAP?

CONVEEN LEG BAG STRAP is a medical device that received FDA 510(k) clearance on 1995-09-13. The listed applicant is Coloplast Corp.. The 510(k) number is K953783.

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

CONVEEN LEG BAG STRAP received FDA 510(k) clearance on 1995-09-13, under 510(k) number K953783.

Who is the listed applicant for CONVEEN LEG BAG STRAP?

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 LEG BAG STRAP?

The FDA product code for CONVEEN LEG BAG STRAP 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 ReliabilityK955609CONVEEN URINE BAG - STERILEColoplast Corp.K953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & SonsK951945PROSYS 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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