The following data is part of a premarket notification filed by Sorensen Research with the FDA for Catheter, Vein, Femoral, Sf 10.
Device ID | K772146 |
510k Number | K772146 |
Device Name: | CATHETER, VEIN, FEMORAL, SF 10 |
Classification | Intracatheter, Dialysis |
Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FJT |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-14 |
Decision Date | 1977-11-29 |