| Device Classification Name |
Drape, Surgical, Antimicrobial
|
| 510(k) Number |
K895011 |
| Device Name |
TRIDENT DRAPE SUPPORT |
| Applicant |
| Trident Medical Products, Inc. |
| 308 S. Henderson |
|
Fort Worth,
TX
76104
|
|
| Applicant Contact |
DAN E BRUHL |
| Correspondent |
| Trident Medical Products, Inc. |
| 308 S. Henderson |
|
Fort Worth,
TX
76104
|
|
| Correspondent Contact |
DAN E BRUHL |
| Regulation Number | 878.4370 |
| Classification Product Code |
|
| Date Received | 08/08/1989 |
| Decision Date | 09/15/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|