FDA 510(k) Application Details - K032119

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K032119
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	PARAGON MEDICAL, INC. 7822 LADUE GLEN FORT WAYNE, IN 46804 US Other 510(k) Applications for this Company
Contact	DAVID C FURR 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	07/09/2003
Decision Date	10/29/2003
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