T:SLIM (TM) INSULIN DELIVERY SYSTEM


Device Classification Name

pump, infusion, insulin

510(k) Number K111210
Device Name T:SLIM (TM) INSULIN DELIVERY SYSTEM
Applicant
TANDEM DIABETES CARE, INC.
11045 roselle street
suite 200
san diego, 
CA 
92121

Applicant Contact don canal
Correspondent
TANDEM DIABETES CARE, INC.
11045 roselle street
suite 200
san diego, 
CA 
92121

Correspodent Contact don canal
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 04/29/2011
Decision Date 11/09/2011
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