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FDA 510(k) Application Details - K112890
Device Classification Name
Massager, Powered Inflatable Tube
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510(K) Number
K112890
Device Name
Massager, Powered Inflatable Tube
Applicant
NORMATEC INDUSTRIES, LP
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20016 US
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Contact
JONATHAN KAHAN
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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
09/30/2011
Decision Date
01/04/2012
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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