The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Temp. Repair Kit-dual Lumen Catheter.
| Device ID | K831587 |
| 510k Number | K831587 |
| Device Name: | TEMP. REPAIR KIT-DUAL LUMEN CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-17 |
| Decision Date | 1983-10-19 |