The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Permcath Tray (2nd Submission).
| Device ID | K895779 |
| 510k Number | K895779 |
| Device Name: | MODIFIED PERMCATH TRAY (2ND SUBMISSION) |
| Classification | Ventilator, Continuous, Facility Use |
| 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 | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-07 |
| Decision Date | 1989-12-07 |