COAMATIC FACTOR VIII— 510(k) K943225

Substantially Equivalent

Pharmacia Hepar, Inc.

FDA 510(k) clearance K943225 for COAMATIC FACTOR VIII, Substantially Equivalent on 1995-11-06. Applicant: Pharmacia Hepar, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia Hepar, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1994-07-06
Decision date: 1995-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.