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FDA 510(k)

HEMOGASTAT

K-Number: K801148 · 1980-06-09

ApplicantTherapac, Inc.
Decision Date1980-06-09
Product CodeJRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOGASTAT is the device name listed in this FDA 510(k) record. The listed applicant is Therapac, Inc.. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801148. The device is classified under product code JRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGASTAT?

HEMOGASTAT is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Therapac, Inc.. The 510(k) number is K801148.

When did HEMOGASTAT receive FDA 510(k) clearance?

HEMOGASTAT received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801148.

Who is the listed applicant for HEMOGASTAT?

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

What is the FDA product code for HEMOGASTAT?

The FDA product code for HEMOGASTAT is JRR.

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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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