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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 Hataas 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
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