The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Lube-lok.
Device ID | K781695 |
510k Number | K781695 |
Device Name: | LUBE-LOK |
Classification | Device, Fixation, Tracheal Tube |
Applicant | OLYMPIC MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-10 |
Decision Date | 1978-11-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LUBE-LOK 77697812 3679760 Live/Registered |
Metal Improvement Company, LLC 2009-03-24 |
LUBE-LOK 71631610 0574981 Dead/Cancelled |
ELECTROFILM CORPORATION 1952-06-23 |