The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Injection Sealing Cap.
| Device ID | K844193 |
| 510k Number | K844193 |
| Device Name: | QUINTON INJECTION SEALING CAP |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Daniel L Roper |
| Correspondent | Daniel L Roper 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 | 1984-10-30 |
| Decision Date | 1985-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521003948 | K844193 | 000 |