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FDA 510(k)

URINARY LEG BAG

K-Number: K780032 · 1978-01-17

ApplicantC.R. Bard, Inc.
Decision Date1978-01-17
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY LEG BAG is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1978-01-17 under 510(k) number K780032. 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 URINARY LEG BAG?

URINARY LEG BAG is a medical device that received FDA 510(k) clearance on 1978-01-17. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K780032.

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

URINARY LEG BAG received FDA 510(k) clearance on 1978-01-17, under 510(k) number K780032.

Who is the listed applicant for URINARY LEG BAG?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINARY LEG BAG?

The FDA product code for URINARY LEG BAG is FAQ.

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Related Devices (Code: FAQ)

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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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