The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Clarity Ultrasonic Surgical Aspirator System.
| Device ID | K182809 |
| 510k Number | K182809 |
| Device Name: | CUSA Clarity Ultrasonic Surgical Aspirator System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Contact | Marybeth Carson |
| Correspondent | Marybeth Carson Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-03 |
| Decision Date | 2018-12-07 |
| Summary: | summary |