FDA 510(k) Application Details - K991931

Device Classification Name Equipment, Traction, Powered

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510(K) Number K991931
Device Name Equipment, Traction, Powered
Applicant THERASYS, INC.
2295 NORTH MORAINE DR.
MORAINE, OH 45439 US
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Contact EARNIE S PHILPOT
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Regulation Number 890.5900

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Classification Product Code ITH
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Date Received 06/08/1999
Decision Date 08/12/1999
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

FDA Source Information for K991931


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