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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 K970850
Device Name SCANRITE DFS
Applicant
Scanrite Systems
43257 Osgood Rd.
Fremont,  CA  94539
Applicant Contact BARRY J WALTER
Correspondent
Scanrite Systems
43257 Osgood Rd.
Fremont,  CA  94539
Correspondent Contact BARRY J WALTER
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/07/1997
Decision Date 05/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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