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FDA 510(k)

GOUGES, ALEXANDER, BISHOP, LUCAS

K-Number: K891901 · 1989-04-12

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-04-12
Product CodeGDH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOUGES, ALEXANDER, BISHOP, LUCAS is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K891901. The device is classified under product code GDH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOUGES, ALEXANDER, BISHOP, LUCAS?

GOUGES, ALEXANDER, BISHOP, LUCAS is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K891901.

When did GOUGES, ALEXANDER, BISHOP, LUCAS receive FDA 510(k) clearance?

GOUGES, ALEXANDER, BISHOP, LUCAS received FDA 510(k) clearance on 1989-04-12, under 510(k) number K891901.

Who is the listed applicant for GOUGES, ALEXANDER, BISHOP, LUCAS?

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

What is the FDA product code for GOUGES, ALEXANDER, BISHOP, LUCAS?

The FDA product code for GOUGES, ALEXANDER, BISHOP, LUCAS is GDH.

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Related Devices (Code: GDH)

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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.

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