FDA 510(k)

TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG

K-Number: K760253 · 1976-08-23

Decision Date1976-08-23

Product CodeGBM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TRAY, UNIVERSAL FOLY WO/DRAINAGE 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 1976-08-23 under 510(k) number K760253. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG?

TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K760253.

When did TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG receive FDA 510(k) clearance?

TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760253.

Who is the listed applicant for TRAY, UNIVERSAL FOLY WO/DRAINAGE 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 TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG?

The FDA product code for TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG is GBM.

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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.