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 |