FDA 510(k) Application Details - K213907

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K213907
Device Name	Wrap, Sterilization
Applicant	Care Essentials Pty Ltd 103 Mornington Street North Geelong 3215 AU Other 510(k) Applications for this Company
Contact	Abhay Sinha 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	12/14/2021
Decision Date	03/14/2022
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