| 510(k) Number |
K870744 |
| Device Name |
SURGICAL STARTER KIT |
| Applicant |
| Devon Industries, Inc. |
| 9530 De Soto Ave. |
|
Chatsworth,
CA
91311
|
|
| Applicant Contact |
ROBERT T HORAN |
| Correspondent |
| Devon Industries, Inc. |
| 9530 De Soto Ave. |
|
Chatsworth,
CA
91311
|
|
| Correspondent Contact |
ROBERT T HORAN |
| Date Received | 02/25/1987 |
| Decision Date | 04/10/1987 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|