510(k) K062457

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES by Baxter Healthcare Corporation — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2006
Date Received
August 23, 2006
Clearance Type
Special
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