Device Classification Name |
knife, ophthalmic
|
510(k) Number |
K873385 |
Device Name |
OPHTHALMIC PHACO-BLADE |
Applicant |
MYOCURE, INC. |
1736 FLOWER ST. |
GLENDALE,
CA
91201
|
|
Applicant Contact |
JENSEN, MD |
Correspondent |
MYOCURE, INC. |
1736 FLOWER ST. |
GLENDALE,
CA
91201
|
|
Correspondent Contact |
JENSEN, MD |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 08/24/1987 |
Decision Date | 09/21/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|