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510(k) K040362

DIAPHARMA FACTOR X KIT by Diapharma Group, Inc. — Product Code GJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2004
Date Received
February 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Factor Deficient
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

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  • K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA (July 31, 2003)
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