Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K860891 |
Device Name |
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE |
Applicant |
INTRA-OPTICS LABS. C/O NEWMAN ASSOC. |
25283 CABOT RD., STE. 207 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
CHARLES H NEWMAN |
Correspondent |
INTRA-OPTICS LABS. C/O NEWMAN ASSOC. |
25283 CABOT RD., STE. 207 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
CHARLES H NEWMAN |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 03/10/1986 |
Decision Date | 04/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|