FDA 510(k)

URETHRAL TRAY W/OUT CAHTETER, 7650

K-Number: K771104 · 1977-06-24

Decision Date1977-06-24

Product CodeFCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URETHRAL TRAY W/OUT CAHTETER, 7650 is the device name listed in this FDA 510(k) record. The listed applicant is Concord Laboratories, Inc.. It received FDA 510(k) clearance on 1977-06-24 under 510(k) number K771104. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETHRAL TRAY W/OUT CAHTETER, 7650?

URETHRAL TRAY W/OUT CAHTETER, 7650 is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K771104.

When did URETHRAL TRAY W/OUT CAHTETER, 7650 receive FDA 510(k) clearance?

URETHRAL TRAY W/OUT CAHTETER, 7650 received FDA 510(k) clearance on 1977-06-24, under 510(k) number K771104.

Who is the listed applicant for URETHRAL TRAY W/OUT CAHTETER, 7650?

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

What is the FDA product code for URETHRAL TRAY W/OUT CAHTETER, 7650?

The FDA product code for URETHRAL TRAY W/OUT CAHTETER, 7650 is FCM.

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Other records listing Concord Laboratories, Inc. as applicant

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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.