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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 K151878
Device Name Video Colposcope
Applicant
Edan Instruments, Inc.
3/F - B, Nanshan Medical Equipments Park
Nanhai Rd. 1019#
Shenzhen,  CN 518067
Applicant Contact Queena Chen
Correspondent
Edan Medical
1200 Crossman Ave., Suite 200
Sunnyvale,  CA  94086
Correspondent Contact Doug Worth
Regulation Number884.1630
Classification Product Code
HEX  
Date Received07/09/2015
Decision Date 12/01/2015
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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