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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 K031436
Device Name MEDISCOPE
Applicant
SOMETECH CORPORATION
6669 PEACHTREE INDUSTRIAL BLVD
SUITE J
NORCROSS,  GA  30092
Applicant Contact KI CHEOL HAN
Correspondent
SOMETECH CORPORATION
6669 PEACHTREE INDUSTRIAL BLVD
SUITE J
NORCROSS,  GA  30092
Correspondent Contact KI CHEOL HAN
Regulation Number884.1630
Classification Product Code
HEX  
Date Received05/06/2003
Decision Date 12/19/2003
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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