FDA 510(k) Application Details - K971542

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K971542
Device Name Stimulator, Muscle, Powered
Applicant REHABILICARE, INC.
1811 OLD HIGHWAY 8
NEW BRIGHTON, MN 55112 US
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Contact GARY L MOORE
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 04/28/1997
Decision Date 08/14/1997
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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