FDA 510(k) Application Details - K203481

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K203481
Device Name	Unit, Cryosurgical, Accessories
Applicant	Recens Medical Inc. 908, SK V1 center, 830 Dongtansunhwan-daero Hwaseong-si 18468 KR Other 510(k) Applications for this Company
Contact	Yeonui Lee 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	11/27/2020
Decision Date	05/13/2021
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