Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
|
510(k) Number |
K950056 |
Device Name |
THE GRIESHABER AXIAL CUTTER |
Applicant |
GRIESHABER & CO. |
1945 VAUGHN RD. |
P.O. BOX 440609 |
KENNESAW,
GA
30144
|
|
Applicant Contact |
FRANK J TIGHE |
Correspondent |
GRIESHABER & CO. |
1945 VAUGHN RD. |
P.O. BOX 440609 |
KENNESAW,
GA
30144
|
|
Correspondent Contact |
FRANK J TIGHE |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 01/06/1995 |
Decision Date | 05/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|