The following data is part of a premarket notification filed by Sonics & Materials, Inc. with the FDA for Vibra-surge System Model Vs2120.
| Device ID | K971533 |
| 510k Number | K971533 |
| Device Name: | VIBRA-SURGE SYSTEM MODEL VS2120 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SONICS & MATERIALS, INC. KENOSIA AVE. Danbury, CT 06810 |
| Contact | Robert Soloff |
| Correspondent | Robert Soloff SONICS & MATERIALS, INC. KENOSIA AVE. Danbury, CT 06810 |
| 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 | 1997-04-28 |
| Decision Date | 1997-07-25 |
| Summary: | summary |