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FDA 510(k) Application Details - K131362
Device Classification Name
Massager, Vacuum, Light Induced Heating
More FDA Info for this Device
510(K) Number
K131362
Device Name
Massager, Vacuum, Light Induced Heating
Applicant
INMODE MD LTD.
20 HATA'AS STR., SUITE 102
KFAR SABA 44425 IL
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Contact
AHAVA STEIN
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
NUV
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More FDA Info for this Product Code
Date Received
05/13/2013
Decision Date
10/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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