FDA 510(k) Application Details - K220102

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K220102
Device Name	Sterilizer, Steam
Applicant	Shinva Medical Instrument Co., Ltd. Xinhua Medical Scientific Zone, Zibo New & Hi-Tech Industrial Development Zone Zibo 255086 CN Other 510(k) Applications for this Company
Contact	Liu Xiaolin Other 510(k) Applications for this Contact
Regulation Number	880.6880   More FDA Info for this Regulation Number
Classification Product Code	FLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2022
Decision Date	10/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review