The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Central Vein Catherization Kit-14-690-.
| Device ID | K830788 |
| 510k Number | K830788 |
| Device Name: | CENTRAL VEIN CATHERIZATION KIT-14-690- |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-14 |
| Decision Date | 1983-04-30 |