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 |