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FDA 510(k) Application Details - K161907
Device Classification Name
Massager, Powered Inflatable Tube
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510(K) Number
K161907
Device Name
Massager, Powered Inflatable Tube
Applicant
XIAMEN SENYANG CO., LTD.
4-5 FLOOR, XINGBEI INDUSTRY, NO 95-99, WEST 2 ROAD,
JIU TIANHU
XINGLIN XIAMEN 361000 CN
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XINJIE SHAO
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
07/12/2016
Decision Date
02/23/2017
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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