FDA 510(k) Application Details - K023997

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K023997
Device Name Stimulator, Muscle, Powered
Applicant TENSCARE LTD.
76 STOCKPORT ROAD
TIMPERLEY, CHESHIRE WA15 7SN GB
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Contact BERNARD J TREMAINE
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 12/03/2002
Decision Date 03/03/2003
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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