The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Optivantage Dh Injector System With Enhanced Communication.
| Device ID | K063503 |
| 510k Number | K063503 |
| Device Name: | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION |
| Classification | Injector, Contrast Medium, Automatic |
| 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 | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2007-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10746190004813 | K063503 | 000 |
| 10746190002727 | K063503 | 000 |
| 10746190004004 | K063503 | 000 |
| 10746190004011 | K063503 | 000 |
| 10746190004028 | K063503 | 000 |
| 10746190004035 | K063503 | 000 |
| 10746190004332 | K063503 | 000 |
| 10746190004349 | K063503 | 000 |
| 10746190004356 | K063503 | 000 |
| 10746190004363 | K063503 | 000 |
| 10746190004714 | K063503 | 000 |
| 10746190004745 | K063503 | 000 |
| 10746190004752 | K063503 | 000 |
| 10746190004806 | K063503 | 000 |
| 10746190002710 | K063503 | 000 |