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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 K073237
Device Name REHASTIM & REHAMOVE
Applicant
Hasomed GmbH
Paul-Ecke-Strasse 1
Magdeburg,  DE 39114
Applicant Contact MATTHIAS WEBER
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number882.5810
Classification Product Code
GZI  
Date Received11/16/2007
Decision Date 12/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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