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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Rectilinear, Nuclear
510(k) Number K882453
Device Name POLYSCAN DIGITAL SCANNER
Applicant
Medical and Scientific Enterprises, Inc.
56 Union Ave.
P.O. Box 806
Sudbury,  MA  01776
Applicant Contact EDUARD J BOTZ
Correspondent
Medical and Scientific Enterprises, Inc.
56 Union Ave.
P.O. Box 806
Sudbury,  MA  01776
Correspondent Contact EDUARD J BOTZ
Regulation Number892.1300
Classification Product Code
IYW  
Date Received06/14/1988
Decision Date 11/23/1988
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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