FDA 510(k) Application Details - K003433

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K003433
Device Name Stimulator, Muscle, Powered
Applicant STERNE EQUIPMENT CO., LTD.
7 RESEARCH RD.
BRAMPTON, ON. L6W 1P4 CA
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Contact THOMAS WALLACE
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 11/06/2000
Decision Date 06/15/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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