FDA 510(k) Application Details - K041038

Device Classification Name	Container, I.V.   More FDA Info for this Device
510(K) Number	K041038
Device Name	Container, I.V.
Applicant	CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. ENTERPRISE PARK DOVER, NH 03820 US Other 510(k) Applications for this Company
Contact	KEITH PALUCH Other 510(k) Applications for this Contact
Regulation Number	880.5025   More FDA Info for this Regulation Number
Classification Product Code	KPE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2004
Decision Date	12/21/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review