| 510(k) Number |
K861161 |
| Device Name |
SURGI-TIE LOOPS |
| Applicant |
| Healthmed Corp. |
| 2815 Baird Rd. |
|
Fairport,
NY
14450
|
|
| Applicant Contact |
D. L FAGAN |
| Correspondent |
| Healthmed Corp. |
| 2815 Baird Rd. |
|
Fairport,
NY
14450
|
|
| Correspondent Contact |
D. L FAGAN |
| Date Received | 03/28/1986 |
| Decision Date | 06/10/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|