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FDA 510(k)

HUMAN O BUFFER

K-Number: K771956 · 1977-10-28

ApplicantFlow Laboratories, Inc.
Decision Date1977-10-28
Product CodeGOK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HUMAN O BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1977-10-28 under 510(k) number K771956. The device is classified under product code GOK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN O BUFFER?

HUMAN O BUFFER is a medical device that received FDA 510(k) clearance on 1977-10-28. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K771956.

When did HUMAN O BUFFER receive FDA 510(k) clearance?

HUMAN O BUFFER received FDA 510(k) clearance on 1977-10-28, under 510(k) number K771956.

Who is the listed applicant for HUMAN O BUFFER?

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

What is the FDA product code for HUMAN O BUFFER?

The FDA product code for HUMAN O BUFFER is GOK.

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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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