Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K031225 |
Device Name |
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 |
Applicant |
GFE MEDIZINTECHNIK GMBH |
6254 SOUTH 1280 EAST |
SALT LAKE CITY,
UT
84121
|
|
Applicant Contact |
JOHN E SAWYER |
Correspondent |
GFE MEDIZINTECHNIK GMBH |
6254 SOUTH 1280 EAST |
SALT LAKE CITY,
UT
84121
|
|
Correspondent Contact |
JOHN E SAWYER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/17/2003 |
Decision Date | 09/29/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|