The following data is part of a premarket notification filed by Laminar Flow Industries with the FDA for Flo-temp.
Device ID | K810021 |
510k Number | K810021 |
Device Name: | FLO-TEMP |
Classification | Monitor, Temperature, Dialysis |
Applicant | LAMINAR FLOW INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLA |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-05 |
Decision Date | 1981-01-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FLO-TEMP 74082894 1728867 Dead/Cancelled |
Tuthill Corporation 1990-07-30 |