510(k) K052999

SEMPERFLO INFUSION SYSTEM by Ethicon, Inc. — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2006
Date Received
October 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type