510(k) K071222

INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES by Baxter Healthcare Corp — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2007
Date Received
May 2, 2007
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