The following data is part of a premarket notification filed by Sra Developments, Ltd. with the FDA for Series 3 Lotus Laparoscopic Ultrasound Surgery System.
| Device ID | K063531 |
| 510k Number | K063531 |
| Device Name: | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SRA DEVELOPMENTS, LTD. BREMRIDGE HOUSE Ashburton, Devon, GB Tq13 7jx |
| Contact | Michael J.r. Young |
| Correspondent | Michael J.r. Young 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-22 |
| Decision Date | 2007-02-22 |
| Summary: | summary |