The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Optistar Mr Injector System.
| Device ID | K984088 |
| 510k Number | K984088 |
| Device Name: | OPTISTAR MR INJECTOR SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Contact | Bridget Drake |
| Correspondent | Bridget Drake 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 | 1998-11-16 |
| Decision Date | 1999-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30746190002219 | K984088 | 000 |
| 30746190002202 | K984088 | 000 |
| 30746190002196 | K984088 | 000 |
| 30746190002189 | K984088 | 000 |