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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 K122311
Device Name GC-3000E DIGITAL COLPOSCOPE
Applicant
SHENZHEN GOLDCARE MEDITECH CO., LTD.
2600 MISSION STREET
SUITE 100
SAN MARINO,  CA  91108
Applicant Contact JIMMY WU
Correspondent
SHENZHEN GOLDCARE MEDITECH CO., LTD.
2600 MISSION STREET
SUITE 100
SAN MARINO,  CA  91108
Correspondent Contact JIMMY WU
Regulation Number884.1630
Classification Product Code
HEX  
Date Received08/01/2012
Decision Date 09/18/2013
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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