FDA 510(k) Application Details - K030403

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K030403
Device Name Stimulator, Muscle, Powered
Applicant CEFAR MEDICAL AB
6740 RIVERVIEW TERRACE
MINNEAPOLIS, MN 55432 US
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Contact CONSTANCE G BUNDY
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 02/06/2003
Decision Date 07/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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