The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Custom Tubing Sets.
| Device ID | K790604 |
| 510k Number | K790604 |
| Device Name: | CUSTOM TUBING SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-19 |
| Decision Date | 1979-05-04 |