FDA 510(k) Application Details - K974198

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K974198
Device Name	Set, I.V. Fluid Transfer
Applicant	CLINICO 5 ROBERT-KOCH-STRASSE BAD HERSFELD D-36251 DE Other 510(k) Applications for this Company
Contact	REINHARD HOPF 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	11/10/1997
Decision Date	12/22/1997
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