510(k) K020418

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES by P.T. Greenleaf — Product Code MEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2003
Date Received
February 7, 2002
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