FDA 510(k) Application Details - K972719

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K972719
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	MEDICEL, S.A. DE C.V. 12300 TWINBROOK PKWY. SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	KCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/1997
Decision Date	02/04/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review