The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Perm. Repair Kit For Leonard Norton Dual.
| Device ID | K830969 |
| 510k Number | K830969 |
| Device Name: | PERM. REPAIR KIT FOR LEONARD NORTON DUAL |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-28 |
| Decision Date | 1983-04-14 |