510(k) K880006

STA-SET I.V. FLOW REGULATOR by Controlled Flow , Ltd. — Product Code LDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
January 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type