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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
De Novo Number DEN130040
510(K) Number K132695
Device Name IOGYN SYSTEM
Requester
IOGYN, INC.
20195 stevens creek boulevard
suite 120
cupertino,  CA  95014
Contact mary edwards
Regulation Number884.1710
Classification Product Code
PGT  
Date Received08/30/2013
Decision Date 03/28/2014
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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