LOTUS

Instrument, Ultrasonic Surgical

SRA DEVELOPMENTS, LTD.

The following data is part of a premarket notification filed by Sra Developments, Ltd. with the FDA for Lotus.

Pre-market Notification Details

• Device ID: K032424
• 510k Number: K032424
• Device Name: LOTUS
• Classification: Instrument, Ultrasonic Surgical
• Applicant: SRA DEVELOPMENTS, LTD. 2305 GOLD MINE ROAD Brookeville, MD 20833
• Contact: T Whit Athey
• Correspondent: T Whit Athey; SRA DEVELOPMENTS, LTD. 2305 GOLD MINE ROAD Brookeville, MD 20833
• 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: 2003-08-05
• Decision Date: 2003-12-16
• Summary: summary