The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton White Sealing Cap.
| Device ID | K850369 |
| 510k Number | K850369 |
| Device Name: | QUINTON WHITE SEALING CAP |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-31 |
| Decision Date | 1985-02-15 |