510(k) K911791

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP by Pharmacia Deltec, Inc. — Product Code MEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1991
Date Received
April 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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