The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Beta Cap System.
| Device ID | K780449 |
| 510k Number | K780449 |
| Device Name: | BETA CAP SYSTEM |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | QUINTON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-20 |
| Decision Date | 1978-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521003917 | K780449 | 000 |
| 10884521003927 | K780449 | 000 |