FDA 510(k) Application Details - K062100

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K062100
Device Name	Wrap, Sterilization
Applicant	ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ARTHUR WARD 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	07/24/2006
Decision Date	12/05/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review