FDA 510(k) Application Details - K972134

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K972134
Device Name	Set, I.V. Fluid Transfer
Applicant	REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT ALPHARETTA, GA 30005 US Other 510(k) Applications for this Company
Contact	DON ROSVOLD Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/1997
Decision Date	08/26/1997
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