The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Norton Flow Directed Thermodilution Cath.
| Device ID | K820229 |
| 510k Number | K820229 |
| Device Name: | NORTON FLOW DIRECTED THERMODILUTION CATH |
| Classification | Catheter, Flow Directed |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-27 |
| Decision Date | 1982-02-12 |