SYMPHONY GLUCOSE MANAGEMENT SYSTEM


Device Classification Name

pump, infusion, insulin

510(k) Number K080639
Device Name SYMPHONY GLUCOSE MANAGEMENT SYSTEM
Applicant
ANIMAS CORP.
200 lawrence dr.
west chester, 
PA 
19380

Applicant Contact amy smith
Correspondent
ANIMAS CORP.
200 lawrence dr.
west chester, 
PA 
19380

Correspodent Contact amy smith
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 03/06/2008
Decision Date 06/24/2008
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

Recalls CDRH Recalls