| Device Classification Name |
Forceps, Ophthalmic
|
| 510(k) Number |
K864266 |
| Device Name |
OPHTHALMIC KNIFE & FORCEPS |
| Applicant |
| Western Medical Products, Inc. |
| 15010 Ventura Blvd. |
| Suite 220 |
|
Sherman Oaks,
CA
91403
|
|
| Applicant Contact |
LA HABA |
| Correspondent |
| Western Medical Products, Inc. |
| 15010 Ventura Blvd. |
| Suite 220 |
|
Sherman Oaks,
CA
91403
|
|
| Correspondent Contact |
LA HABA |
| Regulation Number | 886.4350 |
| Classification Product Code |
|
| Date Received | 10/29/1986 |
| Decision Date | 11/28/1986 |
| 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
|
|
|