ALPHA INFUSION PUMP AND CATHETERS


Device Classification Name

pump, infusion, elastomeric

510(k) Number K021964
Device Name ALPHA INFUSION PUMP AND CATHETERS
Original Applicant
ADVANCED INFUSION, INC.
6200 south mcclintock #6
tempe, 
AZ 
85283

Original Contact james christensen
Regulation Number 880.5725
Classification Product Code
MEB  
Date Received 06/14/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No