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FDA 510(k) Application Details - K201645
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K201645
Device Name
Massager, Powered Inflatable Tube
Applicant
JKH USA, LLC
20505 Valley Blvd. Suite 108
Walnut, CA 91789 US
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Contact
Bill Quanqin Dai
Other 510(k) Applications for this Contact
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
06/17/2020
Decision Date
09/15/2020
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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