The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Bent Neck Curlcath Peritoneal Dialysis Kit.
| Device ID | K874632 |
| 510k Number | K874632 |
| Device Name: | BENT NECK CURLCATH PERITONEAL DIALYSIS KIT |
| Classification | System, Peritoneal, Automatic Delivery |
| 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 | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1987-12-29 |