ULTRA EASE

System, Imaging, Pulsed Echo, Ultrasonic

LECTEC CORP.

The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Ultra Ease.

Pre-market Notification Details

• Device ID: K950943
• 510k Number: K950943
• Device Name: ULTRA EASE
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343
• Contact: Jull R Krall
• Correspondent: Jull R Krall; LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-02-16
• Decision Date: 1996-03-07
• Summary: summary