| 510(k) Number |
K861804 |
| Device Name |
MEDCARE SUTURE REMOVAL KIT |
| Applicant |
| Medcomp Technologies, Inc. |
| 2555 Baird Rd. |
|
Penfield,
NY
14526
|
|
| Applicant Contact |
WILDEMAN |
| Correspondent |
| Medcomp Technologies, Inc. |
| 2555 Baird Rd. |
|
Penfield,
NY
14526
|
|
| Correspondent Contact |
WILDEMAN |
| Date Received | 05/09/1986 |
| Decision Date | 05/23/1986 |
| 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
|
|
|