Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K961738 |
Device Name |
VIT COMMANDER SYSTEM |
Applicant |
SCIERAN TECHNOLOGIES, INC. |
27071 CABOT RD., SUITE 127 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
ROD ROSS |
Correspondent |
SCIERAN TECHNOLOGIES, INC. |
27071 CABOT RD., SUITE 127 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
ROD ROSS |
Regulation Number | 886.4150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/03/1996 |
Decision Date | 11/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|