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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K030403
Device Name CEFAR REHAB 2 AND REHAB 2 PRO
Applicant
Cefar Medical AB
6740 Riverview Terrace
Minneapolis,,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Cefar Medical AB
6740 Riverview Terrace
Minneapolis,,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/06/2003
Decision Date 07/17/2003
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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