The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Sonotome Ultrasonic Aspirator Tips.
| Device ID | K010637 |
| 510k Number | K010637 |
| Device Name: | SONOTOME ULTRASONIC ASPIRATOR TIPS |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
| Contact | Alan T Beckman |
| Correspondent | Alan T Beckman SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
| 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 | 2001-03-05 |
| Decision Date | 2001-04-20 |