The following data is part of a premarket notification filed by Whitehall/div Columbus Mckennon Corp. with the FDA for Themalator. Models T-4-s, T-8-s, Etc..
Device ID | K950350 |
510k Number | K950350 |
Device Name: | THEMALATOR. MODELS T-4-S, T-8-S, ETC. |
Classification | Unit, Heating, Powered |
Applicant | WHITEHALL/DIV COLUMBUS MCKENNON CORP. 15058 PROCTOR AVE. P.O. BOX 3527 City Of Industry, CA 91744 |
Contact | Richard E Uhlig |
Correspondent | Richard E Uhlig WHITEHALL/DIV COLUMBUS MCKENNON CORP. 15058 PROCTOR AVE. P.O. BOX 3527 City Of Industry, CA 91744 |
Product Code | IRQ |
CFR Regulation Number | 890.5950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-30 |
Decision Date | 1995-03-24 |