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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Transport, Patient, Powered
510(k) Number K130864
Device Name C-MAX+ (PLUS)
Applicant
Aat Alber Antriebstechnik GmbH
2611 Shark Cir.
Texas City,  TX  77591
Applicant Contact STEFANIE D BANKSTON
Correspondent
Aat Alber Antriebstechnik GmbH
2611 Shark Cir.
Texas City,  TX  77591
Correspondent Contact STEFANIE D BANKSTON
Regulation Number890.5150
Classification Product Code
ILK  
Date Received03/28/2013
Decision Date 02/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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