FDA 510(k) Application Details - K181993

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K181993
Device Name	Sterilizer, Steam
Applicant	Sturdy Industrial Co., Ltd No. 168 Sec. 1, Zhongxing Road, Wugu District New Taipei City 24872 TW Other 510(k) Applications for this Company
Contact	Wolfgang Huang 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	07/26/2018
Decision Date	11/01/2019
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