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FDA 510(k) Application Details - K130385
Device Classification Name
Massager, Powered Inflatable Tube
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510(K) Number
K130385
Device Name
Massager, Powered Inflatable Tube
Applicant
MAXSTAR INDUSTRIAL CO. LTD.
4568 W. 1ST STREET, STE 104
LOS ANGELES, CA 90004 US
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Contact
DANIEL NAM
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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
02/15/2013
Decision Date
02/18/2014
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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