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FDA 510(k) Application Details - K003909
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K003909
Device Name
Massager, Powered Inflatable Tube
Applicant
PROACT CO.
PO BOX 1026
MT PLEASANT, SC 29465-1026 US
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Contact
JEAN ROZINT
Other 510(k) Applications for this Contact
Regulation Number
890.5650
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Classification Product Code
IRP
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More FDA Info for this Product Code
Date Received
12/19/2000
Decision Date
06/13/2001
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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