FDA 510(k) Application Details - K962462

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K962462
Device Name Stimulator, Muscle, Powered
Applicant SMITH AND NEPHEW DONJOY, INC.
2777 LOKER AVENUE WEST
CARSBAD, CA 92008-6601 US
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Contact DAN W MILLER
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 06/25/1996
Decision Date 09/23/1996
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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