510(k) K994111

CELSITE, MODELS ST401L, ST405L by B. Braun/Mcgaw — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2000
Date Received
December 6, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type