The following data is part of a premarket notification filed by Sra Developments, Ltd. with the FDA for Lotus Series 4 Ultrasonic Surgical System & Accessories.
| Device ID | K151101 |
| 510k Number | K151101 |
| Device Name: | Lotus Series 4 Ultrasonic Surgical System & Accessories |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SRA DEVELOPMENTS, LTD. BREMRIDGE HOUSE Ashburton, Devon, GB Tq13 7jx |
| Contact | Alan Chivers |
| Correspondent | Alan Chivers SRA DEVELOPMENTS, LTD. BREMRIDGE HOUSE Ashburton, Devon, GB Tq13 7jx |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-24 |
| Decision Date | 2015-07-17 |
| Summary: | summary |