The following data is part of a premarket notification filed by Sorensen Research with the FDA for Filter Set, Pmf 1448.
Device ID | K760637 |
510k Number | K760637 |
Device Name: | FILTER SET, PMF 1448 |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-14 |
Decision Date | 1976-10-15 |