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 |