The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for 10.5 French Dilator, 15cm, W/luer Lock.
| Device ID | K841995 |
| 510k Number | K841995 |
| Device Name: | 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | QUINTON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-15 |
| Decision Date | 1984-07-02 |