FDA 510(k)

G-MARK

K-Number: K880076 · 1988-07-01

Decision Date1988-07-01

Product CodeLIC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

G-MARK is the device name listed in this FDA 510(k) record. The listed applicant is Bainbridge Laboratories, Inc.. It received FDA 510(k) clearance on 1988-07-01 under 510(k) number K880076. The device is classified under product code LIC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-MARK?

G-MARK is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Bainbridge Laboratories, Inc.. The 510(k) number is K880076.

When did G-MARK receive FDA 510(k) clearance?

G-MARK received FDA 510(k) clearance on 1988-07-01, under 510(k) number K880076.

Who is the listed applicant for G-MARK?

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

What is the FDA product code for G-MARK?

The FDA product code for G-MARK is LIC.

Other records listing Bainbridge Laboratories, Inc. as applicant

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.

K912215PYLORITRAK

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.