The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Additional 13.4cm. French Catheter Insertion Tray.
| Device ID | K870675 |
| 510k Number | K870675 |
| Device Name: | ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY |
| Classification | Catheter, Percutaneous |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Mary-lee Donoghue |
| Correspondent | Mary-lee Donoghue QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-19 |
| Decision Date | 1987-04-09 |