K830969 is an FDA 510(k) clearance for the PERM. REPAIR KIT FOR LEONARD NORTON DUAL. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1983, 17 days after receiving the submission on March 28, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K830969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1983 |
| Decision Date | April 14, 1983 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |