DANA 3CC SYRINGE INSULIN RESERVOIR

Device Classification Name

accessories, pump, infusion

510(k) Number K071418
Device Name DANA 3CC SYRINGE INSULIN RESERVOIR
Applicant
SOOIL DEVELOPMENT CO., LTD.
49 plain street
north attleboro, 
MA 
02760

Applicant Contact cynthia nolte, ph.d
Correspondent
SOOIL DEVELOPMENT CO., LTD.
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact cynthia nolte, ph.d
Regulation Number 880.5725
Classification Product Code
MRZ  
Date Received 05/22/2007
Decision Date 09/04/2007
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