K951512 is an FDA 510(k) clearance for the PRECISE HOSPITAL FOAM CLEANER DISINFECTANT. This device is classified as a Disinfectant, Medical Devices (Class I - General Controls, product code LRJ).
Submitted by Caltech Industries, Inc. (Midland, US). The FDA issued a Cleared decision on August 7, 1995, 126 days after receiving the submission on April 3, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6890.
| 510(k) Number | K951512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1995 |
| Decision Date | August 07, 1995 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LRJ — Disinfectant, Medical Devices |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6890 |