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FDA 510(k) Application Details - K141848
Device Classification Name
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510(K) Number
K141848
Device Name
IOGYN SYSTEM
Applicant
IOGYN, INC.
20195 STEVENS CREEK BOULEVARD
SUITE 120
CUPERTINO, CA 95014 US
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Contact
RICH CHRISTENSEN
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Regulation Number
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Classification Product Code
PGT
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Date Received
07/09/2014
Decision Date
08/29/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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