The following data is part of a premarket notification filed by Sorensen Research with the FDA for Tall Floor Stand Tfs-01.
Device ID | K831939 |
510k Number | K831939 |
Device Name: | TALL FLOOR STAND TFS-01 |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-16 |
Decision Date | 1983-07-19 |