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FDA 510(k) Application Details - K143197
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K143197
Device Name
Massager, Powered Inflatable Tube
Applicant
NICE RECOVERY SYSTEMS, LLC
1382 KALMIA AVE,
BOULDER, CO 80304 US
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Contact
MICHAEL ROSS
Other 510(k) Applications for this Contact
Regulation Number
890.5650
More FDA Info for this Regulation Number
Classification Product Code
IRP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2014
Decision Date
12/23/2014
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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