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 |