The following data is part of a premarket notification filed by Sorensen Research with the FDA for Blood Filter, Microemboli-ats-f10.
Device ID | K780145 |
510k Number | K780145 |
Device Name: | BLOOD FILTER, MICROEMBOLI-ATS-F10 |
Classification | Microfilter, Blood Transfusion |
Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-30 |
Decision Date | 1978-02-02 |