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FDA 510(k) Application Details - K200616
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K200616
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
E-SWIN
Rue des Cotes D'orval, ZA de la prevote
Houdan 78550 FR
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Contact
Emeric OBIN
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Regulation Number
878.4810
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Classification Product Code
ONF
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More FDA Info for this Product Code
Date Received
03/09/2020
Decision Date
06/11/2020
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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