The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Ultra Ease.
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ULTRA EASE 74604449 not registered Dead/Abandoned |
LecTec Corporation 1994-11-29 |