The following data is part of a premarket notification filed by Sorex Medical with the FDA for Trach-eze.
Device ID | K903740 |
510k Number | K903740 |
Device Name: | TRACH-EZE |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
Contact | Joseph Sorenson |
Correspondent | Joseph Sorenson SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-16 |
Decision Date | 1990-12-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TRACH-EZE 74698822 2139393 Dead/Cancelled |
C.R. BARD, INC. 1995-07-10 |
![]() TRACH-EZE 74278792 not registered Dead/Abandoned |
SORENSON LABORATORIES, INC. 1992-05-26 |