The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Optyx.
Device ID | K904883 |
510k Number | K904883 |
Device Name: | OPTYX |
Classification | Shunt, Central Nervous System And Components |
Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
Contact | Jack P Douglas |
Correspondent | Jack P Douglas BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-26 |
Decision Date | 1991-07-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPTYX 87597518 not registered Live/Pending |
Kantro, Scott 2017-09-06 |
OPTYX 78721816 3186261 Dead/Cancelled |
McKesson Corporation 2005-09-27 |
OPTYX 76262858 2652624 Live/Registered |
Key Technology, Inc. 2001-05-25 |
OPTYX 76185160 2562543 Dead/Cancelled |
EBONITE HOLDING, INC. 2000-12-21 |