| Device Classification Name |
Sponge, Ophthalmic
|
| 510(k) Number |
K130117 |
| Device Name |
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS |
| Applicant |
| Network Medical Products, Ltd. |
| Coronet House, Kearsley Rd. |
|
Ripon,
GB
HG4 2SG
|
|
| Applicant Contact |
ALISON MARCH |
| Correspondent |
| Network Medical Products, Ltd. |
| Coronet House, Kearsley Rd. |
|
Ripon,
GB
HG4 2SG
|
|
| Correspondent Contact |
ALISON MARCH |
| Regulation Number | 886.4790 |
| Classification Product Code |
|
| Date Received | 01/16/2013 |
| Decision Date | 10/29/2013 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|