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FDA 510(k) Application Details - K991931
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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