FDA 510(k) Application Details - K220133

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K220133
Device Name	Wrap, Sterilization
Applicant	Weihai Hongyu Nonwoven Fabric Products Co., Ltd. No.567, Gushan Road, Area of Economy and Technique Weihai 264207 CN Other 510(k) Applications for this Company
Contact	Bin Dong Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2022
Decision Date	03/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review