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510(k) K042760

PEFAKIT APC-R FACTOR V LEIDEN CONTROLS by Pentapharm , Ltd. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2004
Date Received
October 5, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Pentapharm , Ltd.

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