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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K123330
Device Name IOGYN ENDOSCOPE
Applicant
Iogyn, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact Mary J Edwards
Correspondent
Iogyn, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact Mary J Edwards
Regulation Number884.1690
Classification Product Code
HIH  
Date Received10/26/2012
Decision Date 03/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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