The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for L-f Coiled Extension Tubing.
| Device ID | K882329 |
| 510k Number | K882329 |
| Device Name: | L-F COILED EXTENSION TUBING |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | Thomas F Donohue |
| Correspondent | Thomas F Donohue MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-06 |
| Decision Date | 1988-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10746190002093 | K882329 | 000 |
| 20746190002083 | K882329 | 000 |
| 30746190002059 | K882329 | 000 |
| 20746190002045 | K882329 | 000 |