Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K970673 |
Device Name |
DISPOSABLE VITRECTOMY PROBE |
Applicant |
ALTEX VISION |
2450 FULTON ST., SUITE 304 |
SAN FRANCISCO,
CA
94118
|
|
Applicant Contact |
LEONARD KASTRILEVICH |
Correspondent |
ALTEX VISION |
2450 FULTON ST., SUITE 304 |
SAN FRANCISCO,
CA
94118
|
|
Correspondent Contact |
LEONARD KASTRILEVICH |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 02/24/1997 |
Decision Date | 05/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|