The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Integra Selector Ultrasonic Surgical Aspirator System With Bone Tip.
| Device ID | K071669 |
| 510k Number | K071669 |
| Device Name: | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP |
| 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 | 2007-06-19 |
| Decision Date | 2007-08-17 |
| Summary: | summary |