FDA 510(k) Application Details - K973843

Device Classification Name	Infusor, Pressure, For I.V. Bags   More FDA Info for this Device
510(K) Number	K973843
Device Name	Infusor, Pressure, For I.V. Bags
Applicant	SMITH ASSOC. P.O. BOX 4341 CROFTON, MD 21114-4341 US Other 510(k) Applications for this Company
Contact	E.J. Smith Other 510(k) Applications for this Contact
Regulation Number	880.5420   More FDA Info for this Regulation Number
Classification Product Code	KZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/1997
Decision Date	10/29/1997
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