Device Classification Name |
instrument, vitreous aspiration and cutting, ac-powered
|
510(k) Number |
K853457 |
Device Name |
COBURN I/A SYSTEM |
Applicant |
COBURN OPTICAL IND., INC. |
1365 HAMLET AVE. |
P.O. BOX 2498 |
CLEARWATER,
FL
33516
|
|
Applicant Contact |
JAMES S MILLER |
Correspondent |
COBURN OPTICAL IND., INC. |
1365 HAMLET AVE. |
P.O. BOX 2498 |
CLEARWATER,
FL
33516
|
|
Correspondent Contact |
JAMES S MILLER |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 08/16/1985 |
Decision Date | 10/15/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|