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510(k) K122605

PKS BILL by Gyrus Acmi, Inc. — Product Code HIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2012
Date Received
August 27, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4150
Review Panel
OB
Submission Type

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