FDA 510(k) Application Details - K080198

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K080198
Device Name	Wrap, Sterilization
Applicant	TSO3 INC. 33 BLACK WATCH TRAIL FAIRPORT, NY 14450 US Other 510(k) Applications for this Company
Contact	CHARLES O HANCOCK 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	01/25/2008
Decision Date	05/30/2008
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