FDA 510(k) Application Details - K240862

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K240862
Device Name	Wrap, Sterilization
Applicant	Medicom Group, Inc 2555 Chemin de lÆAviation Pointe-Claire H9P 2Z2 CA Other 510(k) Applications for this Company
Contact	Brent Geiger 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	03/28/2024
Decision Date	06/21/2024
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