The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Dual Lumen Needle (product Change).
| Device ID | K860515 |
| 510k Number | K860515 |
| Device Name: | DUAL LUMEN NEEDLE (PRODUCT CHANGE) |
| Classification | Set, Dialysis, Single Needle (co-axial Flow) |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Donald L Andersen |
| Correspondent | Donald L Andersen QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | LBW |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-03-04 |