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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 K160341
Device Name Colposcope System
Applicant
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD
KERNEL MANSION, ECONOMIC DEVELOPMENT DISTRICT
XUZHOU,  CN 221004
Applicant Contact JING WANG
Correspondent
MID-LINK CONSULTING CO., LTD
P.O BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number884.1630
Classification Product Code
HEX  
Date Received02/08/2016
Decision Date 09/14/2016
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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