FDA 510(k) Application Details - K250321

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K250321
Device Name	Wrap, Sterilization
Applicant	George Courey Inc. 6220, Earnest-Cormier Laval H7C 2T5 CA Other 510(k) Applications for this Company
Contact	Naab Cort 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	02/04/2025
Decision Date	06/06/2025
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