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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 K000551
Device Name IMAGE X-70 PLUS DENTAL X-RAY UNIT
Applicant
Medical Device Consultants, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Medical Device Consultants, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number872.1800
Classification Product Code
EHD  
Date Received02/18/2000
Decision Date 03/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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