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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K132423
Device Name THE GYNOCULAR
Applicant
Gynius AB
Dobelnsgatan 23
Stockholm,  SE 11140
Applicant Contact MATTHEW VOLSKY
Correspondent
Gynius AB
Dobelnsgatan 23
Stockholm,  SE 11140
Correspondent Contact MATTHEW VOLSKY
Regulation Number884.1630
Classification Product Code
HEX  
Date Received08/05/2013
Decision Date 04/08/2014
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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