Device Classification Name |
Instrument, Ultrasonic Surgical
|
510(k) Number |
K190180 |
Device Name |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Applicant |
Integra LifeSciences Corporation |
311 Enterprise Drive |
Plainsboro,
NJ
08536
|
|
Applicant Contact |
Alexandra Wells |
Correspondent |
Integra LifeSciences Corporation |
311 Enterprise Drive |
Plainsboro,
NJ
08536
|
|
Correspondent Contact |
Alexandra Wells |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/01/2019 |
Decision Date | 04/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|