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510(k) K111059

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) by Gyrus Acmi, Inc. — Product Code HIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2011
Date Received
April 18, 2011
Clearance Type
Traditional
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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