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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K972921
Device Name SANKO INTRAORAL DENTAL X-RAY
Applicant
Sanko X-Ray Manufacturing Co., Ltd.
904 Kempsville Rd., Suite 103
Virginia Beach,  VA  23464
Applicant Contact WARREN E SACHS
Correspondent
Sanko X-Ray Manufacturing Co., Ltd.
904 Kempsville Rd., Suite 103
Virginia Beach,  VA  23464
Correspondent Contact WARREN E SACHS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/08/1997
Decision Date 01/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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