The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Non-coring Needles.
| Device ID | K883009 |
| 510k Number | K883009 |
| Device Name: | NON-CORING NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron R Duck |
| Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1988-10-04 |