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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K091628
Device Name OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
Applicant
Protec GmbH & Co. KG
Lichtenberger St. 35
Oberstenfeld,  DE 71720
Applicant Contact JOCHEN KRUPP
Correspondent
Protec GmbH & Co. KG
Lichtenberger St. 35
Oberstenfeld,  DE 71720
Correspondent Contact JOCHEN KRUPP
Regulation Number892.1900
Classification Product Code
IXW  
Date Received06/04/2009
Decision Date 08/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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