FDA 510(k) Application Details - K973103

Device Classification Name	Container, I.V.   More FDA Info for this Device
510(K) Number	K973103
Device Name	Container, I.V.
Applicant	CHARTERMED, INC. 1805 SWARTHMORE AVE. LAKEWOOD, NJ 08701 US Other 510(k) Applications for this Company
Contact	K. ALICE PREVILLE 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	08/19/1997
Decision Date	11/24/1997
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