Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K962496 |
Device Name |
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) |
Applicant |
TISSUE TECHNOLOGIES, INC. |
1370 GREEN ST. |
SAN FRANCISO,
CA
94109
|
|
Applicant Contact |
JESSE KRAMER, PH.D. |
Correspondent |
TISSUE TECHNOLOGIES, INC. |
1370 GREEN ST. |
SAN FRANCISO,
CA
94109
|
|
Correspondent Contact |
JESSE KRAMER, PH.D. |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/26/1996 |
Decision Date | 09/03/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|