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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K024186
Device Name X-VIEW
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 Number872.1800
Classification Product Code
MUH  
Date Received12/19/2002
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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