Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K862188 |
Device Name |
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE |
Applicant |
COBURN OPTICAL IND., INC. |
1365 HAMLET AVE. |
P.O. BOX 2498 |
CLEARWATER,
FL
33516
|
|
Applicant Contact |
ANNETTE M HILLRING |
Correspondent |
COBURN OPTICAL IND., INC. |
1365 HAMLET AVE. |
P.O. BOX 2498 |
CLEARWATER,
FL
33516
|
|
Correspondent Contact |
ANNETTE M HILLRING |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 06/09/1986 |
Decision Date | 08/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|