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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K953117
Device Name SCANMASTER DX
Applicant
Howtek, Inc.
21 Park Ave.
Hudson,  NH  03051
Applicant Contact M. RUSSELL LEONARD
Correspondent
Howtek, Inc.
21 Park Ave.
Hudson,  NH  03051
Correspondent Contact M. RUSSELL LEONARD
Regulation Number892.2030
Classification Product Code
LMA  
Date Received07/03/1995
Decision Date 01/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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