Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K944413 |
Device Name |
ACM PTFE SURGICAL MESH |
Applicant |
AMERICAN CUSTOM MEDICAL, INC. |
3305 66TH ST. |
LUBBOCK,
TX
79413
|
|
Applicant Contact |
BRUCE G RUEFER |
Correspondent |
AMERICAN CUSTOM MEDICAL, INC. |
3305 66TH ST. |
LUBBOCK,
TX
79413
|
|
Correspondent Contact |
BRUCE G RUEFER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 09/08/1994 |
Decision Date | 11/09/1994 |
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
|
|
|