DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS


Device Classification Name

pump, infusion, insulin

510(k) Number K022317
Device Name DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
Original Applicant
SOOIL DEVELOPMENT CO., LTD.
49 plain st.
north attleboro, 
MA 
02760

Original Contact cynthia j.m. nolte
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 07/17/2002
Decision Date 08/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No