FDA 510(k) Application Details - K231661

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K231661
Device Name	Unit, Cryosurgical, Accessories
Applicant	Medinux (Tianjin) Technologies Co., Ltd. Room 401, Unit 3, Building K1 6 Haitai Fazhan 6th Road, Huayuan Industrial Park Tianjin 300384 CN Other 510(k) Applications for this Company
Contact	Diana Zhang 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	06/07/2023
Decision Date	11/27/2023
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