The following data is part of a premarket notification filed by Stantex Pty Ltd. with the FDA for Oxyguard.
Device ID | K914978 |
510k Number | K914978 |
Device Name: | OXYGUARD |
Classification | Endoscopic Bite Block |
Applicant | STANTEX PTY LTD. 144 GREAT NORTH RD., FIVE DOCK Sydney, New South Wales, AU 2046 |
Contact | Thomas J Borody |
Correspondent | Thomas J Borody STANTEX PTY LTD. 144 GREAT NORTH RD., FIVE DOCK Sydney, New South Wales, AU 2046 |
Product Code | MNK |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-06 |
Decision Date | 1992-01-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OXYGUARD 88533522 not registered Live/Pending |
AMERICAN TARTARIC PRODUCTS INC. 2019-07-24 |
OXYGUARD 79253289 not registered Dead/Abandoned |
OXYGUARD INTERNATIONAL A/S 2018-10-25 |
OXYGUARD 79253251 not registered Dead/Abandoned |
OXYGUARD INTERNATIONAL A/S 2018-10-25 |
OXYGUARD 78495650 not registered Dead/Abandoned |
Grunenthal USA, Inc. 2004-10-06 |
OXYGUARD 76702193 not registered Dead/Abandoned |
LIQUA-DRY, INC. 2010-03-22 |
OXYGUARD 75716481 2601628 Live/Registered |
KURARAY CO., LTD. 1999-05-27 |
OXYGUARD 75001174 not registered Dead/Abandoned |
Toyo Seikan Kaisha, Ltd. 1995-10-03 |
OXYGUARD 74314254 1800625 Dead/Cancelled |
Stantex Pty Ltd 1992-09-16 |
OXYGUARD 74304825 1866371 Dead/Cancelled |
Plasco Manufacturing Ltd. 1992-08-14 |
OXYGUARD 74226809 1818380 Live/Registered |
THERMAL GAS SYSTEMS, INC. 1991-12-02 |
OXYGUARD 73555900 1402801 Dead/Cancelled |
TWIN LABORATORIES, INC. 1985-08-29 |