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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K112844
FOIA Releasable 510(k) K112844
Device Name REHASTIM 2, REHAMOVE 2
Applicant
Hasomed GmbH
Paul-Ecke-Strasse 1
Magdeburg,  DE 39114
Applicant Contact MATTHIAS WEBER
Correspondent
Hasomed GmbH
Paul-Ecke-Strasse 1
Magdeburg,  DE 39114
Correspondent Contact MATTHIAS WEBER
Regulation Number882.5810
Classification Product Code
GZI  
Date Received09/29/2011
Decision Date 10/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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