Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K973462 |
Device Name |
SOFTFORM FACIAL IMPLANT |
Applicant |
TISSUE TECHNOLOGIES, INC. |
1370 GREEN ST. |
SAN FRANCISCO,
CA
94109
|
|
Applicant Contact |
JESSE KRAMER, PH.D |
Correspondent |
TISSUE TECHNOLOGIES, INC. |
1370 GREEN ST. |
SAN FRANCISCO,
CA
94109
|
|
Correspondent Contact |
JESSE KRAMER, PH.D |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 09/12/1997 |
Decision Date | 11/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|