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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 K190187
Device Name Gynescope System
Applicant
Illumigyn , Ltd.
Communication Center
Neve Ilan,  IL 9085000
Applicant Contact Lior Greenstein
Correspondent
A. Stein Regulatory Affairs Consulting , Ltd.
20 Hata As St. , Suite 102
Kfar Saba,  IL 4442520
Correspondent Contact Ahava Stein
Regulation Number884.1630
Classification Product Code
HEX  
Subsequent Product Code
HIB  
Date Received02/01/2019
Decision Date 05/08/2019
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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