The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Excel+ Ultrasonic Surgical Aspirator System.
| Device ID | K141668 |
| 510k Number | K141668 |
| Device Name: | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08535 |
| Contact | Janet C Kay |
| Correspondent | Janet C Kay INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08535 |
| 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 | 2014-06-23 |
| Decision Date | 2014-11-06 |
| Summary: | summary |