SURESET 3.0 ML RESERVOIR, MODEL 24-103


Device Classification Name

pump, infusion

510(k) Number K024056
Device Name SURESET 3.0 ML RESERVOIR, MODEL 24-103
Original Applicant
APPLIED DIABETES RESEARCH, INCORPORATED
28481 lafalda
laguna niguel, 
CA 
92677

Original Contact james barley
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 12/09/2002
Decision Date 01/17/2003
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