The following data is part of a premarket notification filed by Sartorius Filters, Inc. with the FDA for Sartorius Minisart Sm 16596hy.
Device ID | K844504 |
510k Number | K844504 |
Device Name: | SARTORIUS MINISART SM 16596HY |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | SARTORIUS FILTERS, INC. 26575 CORPORATE AVE. Hayward, CA 94545 |
Contact | Steven Cates |
Correspondent | Steven Cates SARTORIUS FILTERS, INC. 26575 CORPORATE AVE. Hayward, CA 94545 |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-20 |
Decision Date | 1985-01-18 |