The following data is part of a premarket notification filed by Namic with the FDA for High Pressure Contrast Injection Line.
Device ID | K822100 |
510k Number | K822100 |
Device Name: | HIGH PRESSURE CONTRAST INJECTION LINE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | NAMIC 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 | 1982-07-16 |
Decision Date | 1982-08-24 |