FDA 510(k) Application Details - K233777

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K233777
Device Name	Wrap, Sterilization
Applicant	PRIMED Medical Products Inc. 200, 2003 91 St SW Edmonton T6X 0W8 CA Other 510(k) Applications for this Company
Contact	Mitra Fard 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	11/24/2023
Decision Date	05/24/2024
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