Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K890195 |
Device Name |
JAMES SURGICAL SYSTEM J1000 |
Applicant |
O.R. SPECIALTIES, INC. |
4749 APPLETREE LN. |
TUSCALOOSA,
AL
35405
|
|
Applicant Contact |
JACK W HOWARD |
Correspondent |
O.R. SPECIALTIES, INC. |
4749 APPLETREE LN. |
TUSCALOOSA,
AL
35405
|
|
Correspondent Contact |
JACK W HOWARD |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 01/18/1989 |
Decision Date | 08/03/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|