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FDA 510(k)

COAMATIC FACTOR VIII

K-Number: K943225 · 1995-11-06

ApplicantPharmacia Hepar, Inc.
Decision Date1995-11-06
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAMATIC FACTOR VIII is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Hepar, Inc.. It received FDA 510(k) clearance on 1995-11-06 under 510(k) number K943225. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAMATIC FACTOR VIII?

COAMATIC FACTOR VIII is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is Pharmacia Hepar, Inc.. The 510(k) number is K943225.

When did COAMATIC FACTOR VIII receive FDA 510(k) clearance?

COAMATIC FACTOR VIII received FDA 510(k) clearance on 1995-11-06, under 510(k) number K943225.

Who is the listed applicant for COAMATIC FACTOR VIII?

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

What is the FDA product code for COAMATIC FACTOR VIII?

The FDA product code for COAMATIC FACTOR VIII is GGP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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