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FDA 510(k) Application Details - K221666
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K221666
Device Name
Massager, Powered Inflatable Tube
Applicant
NormaTec Industries, LP
480 Pleasant Street, Suite A200
Watertown, MA 02472 US
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Contact
Steve Henderson
Other 510(k) Applications for this Contact
Regulation Number
890.5650
More FDA Info for this Regulation Number
Classification Product Code
IRP
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More FDA Info for this Product Code
Date Received
06/08/2022
Decision Date
07/14/2022
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
Y
Expedited Review
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