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FDA 510(k) Application Details - K192114
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K192114
Device Name
Massager, Powered Inflatable Tube
Applicant
Cool Systems, Inc. (dba Game Ready)
1800 Sutter Street, Suite 500
Concord, CA 94520 US
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Contact
Natalie Kennel
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
08/06/2019
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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