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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 K944684
Device Name POLYSCAN DIGITAL SCANNER
Applicant
Mse Medizintechnik GmbH & Co. KG
Carl Zeiss Strasses 18, D-6074
Rodemark,  DE D-6074
Applicant Contact EDUARD J BOTZ
Correspondent
Mse Medizintechnik GmbH & Co. KG
Carl Zeiss Strasses 18, D-6074
Rodemark,  DE D-6074
Correspondent Contact EDUARD J BOTZ
Regulation Number892.1300
Classification Product Code
IYW  
Date Received09/22/1994
Decision Date 05/15/1995
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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