Device Classification Name |
instrument, vitreous aspiration and cutting, ac-powered
|
510(k) Number |
K914038 |
Device Name |
POLLY'S CUTTER J-225 |
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 | 09/10/1991 |
Decision Date | 12/09/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|