IOGYN ENDOSCOPE

Hysteroscope (and Accessories)

IOGYN, INC.

The following data is part of a premarket notification filed by Iogyn, Inc. with the FDA for Iogyn Endoscope.

Pre-market Notification Details

Device IDK123330
510k NumberK123330
Device Name:IOGYN ENDOSCOPE
ClassificationHysteroscope (and Accessories)
Applicant IOGYN, INC. 5353 WAYZATA BOULEVARD STE. 505 Minneapolis,  MN  55416
ContactMary J Edwards
CorrespondentMary J Edwards
IOGYN, INC. 5353 WAYZATA BOULEVARD STE. 505 Minneapolis,  MN  55416
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-26
Decision Date2013-03-19
Summary:summary

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