K952302 is an FDA 510(k) clearance for the AMUCHINA. This device is classified as a Disinfectant, Medical Devices (Class I - General Controls, product code LRJ).
Submitted by Amuchina Intl., Inc. (Gaithersburg, US). The FDA issued a Cleared decision on July 26, 1995, 71 days after receiving the submission on May 16, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6890.
| 510(k) Number | K952302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1995 |
| Decision Date | July 26, 1995 |
| Days to Decision | 71 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 |