The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Pvc Lines For Monitoring.
| Device ID | K780985 |
| 510k Number | K780985 |
| Device Name: | PVC LINES FOR MONITORING |
| Classification | Tubing, Noninvasive |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-14 |
| Decision Date | 1978-07-27 |