The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Vesta-syde(r) Interim Instr Decontamination System.
Device ID | K931816 |
510k Number | K931816 |
Device Name: | VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM |
Classification | Disinfectant, Medical Devices |
Applicant | CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
Contact | Michael Ebers |
Correspondent | Michael Ebers CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-08 |
Decision Date | 1994-05-26 |