FDA 510(k) Application Details - K111751

Device Classification Name Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

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510(K) Number K111751
Device Name Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Applicant ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE, NJ 08876-0151 US
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Contact BRIAN A KANERVIKO
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Regulation Number 884.4150

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Classification Product Code HIN
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Date Received 06/22/2011
Decision Date 12/02/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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