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FDA 510(k) Application Details - K201773
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K201773
Device Name
Powered Laser Surgical Instrument
Applicant
Hironic Co., Ltd.
19F,767,Sinsu-Ro, Suji-Gu
Yongin-Si 16827 KR
Other 510(k) Applications for this Company
Contact
Su Yeon Back
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
06/29/2020
Decision Date
10/19/2021
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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