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FDA 510(k)

GOWN, SURGICAL, SURGINE

K-Number: K770250 · 1977-03-07

ApplicantSurgikos, Inc.
Decision Date1977-03-07
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GOWN, SURGICAL, SURGINE is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1977-03-07 under 510(k) number K770250. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOWN, SURGICAL, SURGINE?

GOWN, SURGICAL, SURGINE is a medical device that received FDA 510(k) clearance on 1977-03-07. The listed applicant is Surgikos, Inc.. The 510(k) number is K770250.

When did GOWN, SURGICAL, SURGINE receive FDA 510(k) clearance?

GOWN, SURGICAL, SURGINE received FDA 510(k) clearance on 1977-03-07, under 510(k) number K770250.

Who is the listed applicant for GOWN, SURGICAL, SURGINE?

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

What is the FDA product code for GOWN, SURGICAL, SURGINE?

The FDA product code for GOWN, SURGICAL, SURGINE is BZQ.

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Other records listing Surgikos, 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.

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