The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Vesphene Ii.
Device ID | K931573 |
510k Number | K931573 |
Device Name: | VESPHENE II |
Classification | Disinfectant, Medical Devices |
Applicant | CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
Contact | Michael Ebers |
Correspondent | Michael Ebers CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-30 |
Decision Date | 1994-05-16 |