FDA 510(k) Application Details - K020637

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K020637
Device Name Stimulator, Muscle, Powered
Applicant CARE REHAB AND ORTHOPAEDIC
1124 DOMINION CT.
MCLEAN, VA 22102 US
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Contact CHRISTIAN HUNT
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 02/27/2002
Decision Date 05/28/2002
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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