The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Cusa Excel+.
| Device ID | K150682 |
| 510k Number | K150682 |
| Device Name: | CUSA Excel+ |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Jennifer Siegel |
| Correspondent | Jennifer Siegel INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. 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 | 2015-03-17 |
| Decision Date | 2015-12-18 |
| Summary: | summary |