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 |