Device Classification Name |
Pump, Infusion, Insulin
|
510(k) Number |
K143189 |
Device Name |
t:flex Insulin Delivery System |
Applicant |
Tandem Diabetes Care, Inc. |
11045 Roselle Street |
San Diego,
CA
92121
|
|
Applicant Contact |
John Sheridan |
Correspondent |
Hogan Lovells US LLP |
1835 Market Street, 29th Floor |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice Hogan |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 11/05/2014 |
Decision Date | 01/09/2015 |
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
|
|
|