The following data is part of a premarket notification filed by Calgon Corp. with the FDA for Klenzyme.
| Device ID | K944950 |
| 510k Number | K944950 |
| Device Name: | KLENZYME |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | CALGON CORP. SUB. MERCK & CO., INC. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| Contact | Michael Ebers |
| Correspondent | Michael Ebers CALGON CORP. SUB. MERCK & CO., INC. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-07 |
| Decision Date | 1994-12-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KLENZYME 73790380 1642536 Dead/Cancelled |
ECOLAB INC. 1989-03-31 |
![]() KLENZYME 73682847 1484952 Live/Registered |
MERCK & CO., INC. 1987-09-08 |