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FDA 510(k) Application Details - K191940
Device Classification Name
More FDA Info for this Device
510(K) Number
K191940
Device Name
Palm NRG cellulite and muscle toning body device
Applicant
Heat In A Click
1975 Tigertail Blvd Dania
Homestead, FL 33034 US
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Contact
Guy Levi
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Regulation Number
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Classification Product Code
PBX
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Date Received
07/19/2019
Decision Date
11/03/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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