Device Classification Name |
preamplifier, battery-powered, ophthalmic
|
510(k) Number |
K854793 |
Device Name |
MONOPOLAR INJECTION NEEDLE ELECTRODE |
Applicant |
OCULINUM, INC. |
P. O. BOX 175 |
MILL VALLEY,
CA
94942
|
|
Applicant Contact |
SCOTT, M.D. |
Correspondent |
OCULINUM, INC. |
P. O. BOX 175 |
MILL VALLEY,
CA
94942
|
|
Correspondent Contact |
SCOTT, M.D. |
Regulation Number | 886.1640
|
Classification Product Code |
|
Date Received | 12/05/1985 |
Decision Date | 02/18/1986 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|