The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Pvc Quick Prime Lines.
| Device ID | K780984 |
| 510k Number | K780984 |
| Device Name: | PVC QUICK PRIME LINES |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-14 |
| Decision Date | 1978-07-17 |