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FDA 510(k) Application Details - DEN130040
Device Classification Name
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510(K) Number
DEN130040
Device Name
IOGYN SYSTEM
Applicant
IOGYN, INC.
20195 STEVENS CREEK BOULEVARD
SUITE 120
CUPERTINO, CA 95014 US
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Contact
MARY EDWARDS
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PGT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2013
Decision Date
03/28/2014
Decision
DENG -
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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