The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Syringe With Handi-fil.
| Device ID | K082212 |
| 510k Number | K082212 |
| Device Name: | SYRINGE WITH HANDI-FIL |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-06 |
| Decision Date | 2009-01-22 |
| Summary: | summary |