FDA 510(k) Application Details - K062704

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K062704
Device Name	Wrap, Sterilization
Applicant	WINNER INDUSTRIES (SHENZHEN) CO., LTD. 1O37 WALNUT AVE. POMONA, CA 91766 US Other 510(k) Applications for this Company
Contact	MING XIE 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	09/11/2006
Decision Date	06/08/2007
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