| Device Classification Name |
Clamp, Surgical, General & Plastic Surgery
|
| 510(k) Number |
K855144 |
| Device Name |
TOURIQUET KIT WITH SNARE |
| Applicant |
| Dlp, Inc. |
| 620 Watson SW |
| P.O. Box 409 |
|
Grand Rapids,
MI
49501
|
|
| Applicant Contact |
RONALD A WILLIAM |
| Correspondent |
| Dlp, Inc. |
| 620 Watson SW |
| P.O. Box 409 |
|
Grand Rapids,
MI
49501
|
|
| Correspondent Contact |
RONALD A WILLIAM |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 12/26/1985 |
| Decision Date | 02/05/1986 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|