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FDA 510(k) Application Details - K230599
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K230599
Device Name
Unit, Cryosurgical, Accessories
Applicant
RecensMedical, Inc.
#507, #908, SK V1 center, 830 Dongtansunhwan-daero
Hwaseong-si 18468 KR
Other 510(k) Applications for this Company
Contact
Lee Yeonui
Other 510(k) Applications for this Contact
Regulation Number
878.4350
More FDA Info for this Regulation Number
Classification Product Code
GEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2023
Decision Date
06/22/2023
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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