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FDA 510(k) Application Details - K213557
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K213557
Device Name
Powered Laser Surgical Instrument
Applicant
SNJ Co., Ltd
#604, Ace-Techno Tower 2, Digital ro 31 gil 19
Guro gu
Seoul KR
Other 510(k) Applications for this Company
Contact
Taehi Chang
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/2021
Decision Date
04/12/2022
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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