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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 K013176
Device Name MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
Applicant
Afp Imaging Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Afp Imaging Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number872.1800
Classification Product Code
EHD  
Date Received09/24/2001
Decision Date 10/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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