PEFAKIT APC-R FACTOR V LEIDEN— 510(k) K042762

Substantially Equivalent

Pentapharm , Ltd.

FDA 510(k) clearance K042762 for PEFAKIT APC-R FACTOR V LEIDEN, Substantially Equivalent on 2004-12-22. Applicant: Pentapharm , Ltd..

Clearance details

Applicant: Pentapharm , Ltd.
Product code: Code GGW
Advisory panel: Hematology
Date received: 2004-10-05
Decision date: 2004-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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