OPTIBOLUS
Injector And Syringe, Angiographic
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Optibolus.
Pre-market Notification Details
| Device ID | K031339 |
| 510k Number | K031339 |
| Device Name: | OPTIBOLUS |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Contact | Ellis Rogers |
| Correspondent | Ellis Rogers MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-28 |
| Decision Date | 2003-07-11 |
| Summary: | summary |
Trademark Results [OPTIBOLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIBOLUS 78333769 3194869 Live/Registered |
LIEBEL-FLARSHEIM COMPANY LLC 2003-11-26 |
 OPTIBOLUS 78174357 2849490 Dead/Cancelled |
Mallinckrodt Inc. 2002-10-15 |
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