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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
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