The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Disposable Syringe Fill Tube.
| Device ID | K781334 |
| 510k Number | K781334 |
| Device Name: | DISPOSABLE SYRINGE FILL TUBE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-02 |
| Decision Date | 1978-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20746190002007 | K781334 | 000 |