The following data is part of a premarket notification filed by Calgon Corp. with the FDA for Instru Klenz.
| Device ID | K935063 |
| 510k Number | K935063 |
| Device Name: | INSTRU KLENZ |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | CALGON CORP. P.O. BOX 147 St. Louis, MO 63167 -0147 |
| Contact | Michael Ebers |
| Correspondent | Michael Ebers CALGON CORP. P.O. BOX 147 St. Louis, MO 63167 -0147 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-21 |
| Decision Date | 1994-05-09 |