The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Cusa Shear Tip, An Accessory Of The Cusa Excel Ultrasonic Surgical Aspirator System.
| Device ID | K090864 |
| 510k Number | K090864 |
| Device Name: | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| 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 | 2009-03-30 |
| Decision Date | 2009-05-08 |
| Summary: | summary |