The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Mon-klenz.
| Device ID | K941163 |
| 510k Number | K941163 |
| Device Name: | MON-KLENZ |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
| Contact | Micheal E Bers |
| Correspondent | Micheal E Bers CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-11 |
| Decision Date | 1994-05-18 |