The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Continuous Flush Device, Cat. #14-370.
Device ID | K791890 |
510k Number | K791890 |
Device Name: | CONTINUOUS FLUSH DEVICE, CAT. #14-370 |
Classification | Catheter, Continuous Flush |
Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-25 |
Decision Date | 1979-12-13 |