The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Optistar Elite Injection System.
| Device ID | K073592 |
| 510k Number | K073592 |
| Device Name: | OPTISTAR ELITE INJECTION SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Contact | Dale Moore |
| Correspondent | Dale Moore 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-20 |
| Decision Date | 2008-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10746190005209 | K073592 | 000 |
| 10746190002642 | K073592 | 000 |
| 10746190002871 | K073592 | 000 |
| 10746190002888 | K073592 | 000 |
| 10746190003861 | K073592 | 000 |
| 10746190003878 | K073592 | 000 |
| 10746190003885 | K073592 | 000 |
| 10746190004110 | K073592 | 000 |
| 10746190005179 | K073592 | 000 |
| 10746190005186 | K073592 | 000 |
| 10746190005193 | K073592 | 000 |
| 10746190002635 | K073592 | 000 |