ACCU-CHECK COMBO SYSTEM


Device Classification Name

pump, infusion, insulin

510(k) Number K111353
Device Name ACCU-CHECK COMBO SYSTEM
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact scott thiel
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact scott thiel
Regulation Number 880.5725
Classification Product Code
LZG  
Subsequent Product Codes
NBW   NDC  
Date Received 05/16/2011
Decision Date 07/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls