K951162 is an FDA 510(k) clearance for the PHENO-CEN GERMICIDAL DETERGENT. This device is classified as a Disinfectant, Medical Devices (Class I - General Controls, product code LRJ).
Submitted by Central Solutions, Inc. (Kansas City, US). The FDA issued a Cleared decision on July 11, 1995, 119 days after receiving the submission on March 14, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6890.
| 510(k) Number | K951162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1995 |
| Decision Date | July 11, 1995 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LRJ — Disinfectant, Medical Devices |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6890 |