| Device Classification Name |
Plug, Scleral
|
| 510(k) Number |
K871604 |
| Device Name |
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS |
| Applicant |
| Advanced Surgical Products, Inc. |
| 524 Chele Dr. St. |
|
Charles,
MO
63303
|
|
| Applicant Contact |
TODD HESSEL |
| Correspondent |
| Advanced Surgical Products, Inc. |
| 524 Chele Dr. St. |
|
Charles,
MO
63303
|
|
| Correspondent Contact |
TODD HESSEL |
| Regulation Number | 886.4155 |
| Classification Product Code |
|
| Date Received | 04/24/1987 |
| Decision Date | 06/12/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|