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FDA 510(k) Application Details - K191862
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K191862
Device Name
Massager, Powered Inflatable Tube
Applicant
Guangzhou Longest Science & Technology Co., Ltd.
5&6f, Building B4, No.11, Kaiyuan Avenue, Science City
Guangzhou 510530 CN
Other 510(k) Applications for this Company
Contact
Xiaobing Luo
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
07/11/2019
Decision Date
10/29/2019
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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