FDA 510(k) Application Details - K231893

Device Classification Name	Sterilizer, Chemical   More FDA Info for this Device
510(K) Number	K231893
Device Name	Sterilizer, Chemical
Applicant	LowTem Co., Ltd. 100-2, Cheombok-ro, Dong-gu Daegu-si 41061 KR Other 510(k) Applications for this Company
Contact	Suyeon Lee Other 510(k) Applications for this Contact
Regulation Number	880.6860   More FDA Info for this Regulation Number
Classification Product Code	MLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2023
Decision Date	09/18/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review