Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K141065 |
Device Name |
CONSTELLATION VISION SYSTEM |
Applicant |
ALCON RESEARCH, LTD. |
20511 Lake Forest Dr |
Lake Forest,
CA
92630
|
|
Applicant Contact |
ROBERT LUNDBERG |
Correspondent |
ALCON RESEARCH, LTD. |
20511 Lake Forest Dr |
Lake Forest,
CA
92630
|
|
Correspondent Contact |
ROBERT LUNDBERG |
Regulation Number | 886.4150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/24/2014 |
Decision Date | 08/22/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|