The following data is part of a premarket notification filed by Integra Neurosciences, Ltd. with the FDA for Selector Quantum Ultrasonic Aspirator System.
| Device ID | K042277 |
| 510k Number | K042277 |
| Device Name: | SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA NEUROSCIENCES, LTD. NEWBURY RD. Andover Hampshire, GB Sp10 4dr |
| Contact | Nikki Hinton |
| Correspondent | Nikki Hinton INTEGRA NEUROSCIENCES, LTD. NEWBURY RD. Andover Hampshire, GB Sp10 4dr |
| 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 | 2004-08-23 |
| Decision Date | 2004-09-29 |
| Summary: | summary |