The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Mullins-x, Model 250x.
| Device ID | K082868 |
| 510k Number | K082868 |
| Device Name: | MULLINS-X, MODEL 250X |
| Classification | Catheter, Percutaneous |
| Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Contact | Nichelle Laflesh |
| Correspondent | Nichelle Laflesh NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2008-10-24 |
| Summary: | summary |