510(k) K771875

ULTRAFILTRATION MONITOR 5M9034 by Travenol Laboratories, S.A. — Product Code FIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1977
Date Received
October 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Pass
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type