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510(k) K101606

MICROMED PD-8K INSULATION DEFECT DETECTOR by Mcgan Technology, LLC — Product Code HFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2010
Date Received
June 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

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