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