The following data is part of a premarket notification filed by Sonex Medical with the FDA for Vari-set.
| Device ID | K894111 |
| 510k Number | K894111 |
| Device Name: | VARI-SET |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | SONEX MEDICAL 2511 SOUTH WEST TEMPLE Salt Lake City, UT 84115 |
| Contact | Reed Winterton |
| Correspondent | Reed Winterton SONEX MEDICAL 2511 SOUTH WEST TEMPLE Salt Lake City, UT 84115 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-09-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VARI-SET 73196034 1140717 Dead/Cancelled |
Norlin Industries, Inc. 1978-12-07 |
![]() VARI-SET 72214094 0797684 Dead/Expired |
ECLIPSE FUEL ENGINEERING CO. 1965-03-15 |