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510(k) K010750

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 by Fisher Diagnostics — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2001
Date Received
March 13, 2001
Clearance Type
Traditional
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

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