The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Supplemental Tygon Pac-monitoring Lines.
| Device ID | K780662 |
| 510k Number | K780662 |
| Device Name: | SUPPLEMENTAL TYGON PAC-MONITORING LINES |
| Classification | Stopcock, I.v. Set |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-18 |
| Decision Date | 1978-06-06 |