Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K121134 |
Device Name |
TL TRISEB CREAM |
Applicant |
TRIGEN LABORATORIES, INC. |
11705 BOYETTE RD, STE 171 |
RIVERVIEW,
FL
33569
|
|
Applicant Contact |
MELISSA GOODHEAD |
Correspondent |
TRIGEN LABORATORIES, INC. |
11705 BOYETTE RD, STE 171 |
RIVERVIEW,
FL
33569
|
|
Correspondent Contact |
MELISSA GOODHEAD |
Classification Product Code |
|
Date Received | 04/13/2012 |
Decision Date | 07/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|