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FDA 510(k) Application Details - K212561
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K212561
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ILOODA Co., Ltd
120, Jangan-ro 458 Beon-gil, Jangan-Gu
Suwon-si 16200 KR
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Contact
Yun-Jung Ha
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
08/13/2021
Decision Date
09/27/2022
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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