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FDA 510(k)

RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)

K-Number: K770804 · 1977-05-20

ApplicantFlow Laboratories, Inc.
Decision Date1977-05-20
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) 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 1977-05-20 under 510(k) number K770804. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)?

RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K770804.

When did RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) receive FDA 510(k) clearance?

RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770804.

Who is the listed applicant for RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)?

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 RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)?

The FDA product code for RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) is GQG.

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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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