The following data is part of a premarket notification filed by Caltech Industries, Inc. with the FDA for Precise Hospital Foam Cleaner Disinfectant.
Device ID | K951512 |
510k Number | K951512 |
Device Name: | PRECISE HOSPITAL FOAM CLEANER DISINFECTANT |
Classification | Disinfectant, Medical Devices |
Applicant | CALTECH INDUSTRIES, INC. 2420 SCHUETTE DR. Midland, MI 48642 |
Contact | Donald Johnson |
Correspondent | Donald 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 | 1995-04-03 |
Decision Date | 1995-08-07 |