The following data is part of a premarket notification filed by Caltech Industries, Inc. with the FDA for Dispatch Hospital Cleaner Disinfectant Towels With Bleach.
Device ID | K983869 |
510k Number | K983869 |
Device Name: | DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH |
Classification | Disinfectant, Medical Devices |
Applicant | CALTECH INDUSTRIES, INC. 2420 SCHUETTE DR. Midland, MI 48642 |
Contact | Donald A Johnson |
Correspondent | Donald A Johnson CALTECH INDUSTRIES, INC. 2420 SCHUETTE DR. Midland, MI 48642 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-02 |
Decision Date | 1998-11-30 |