510(k) K942046

PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE by Pharmacia Deltec, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1994
Date Received
April 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type