K955850 is an FDA 510(k) clearance for the PRO-TECH. 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 February 9, 1996, 44 days after receiving the submission on December 27, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6890.
| 510(k) Number | K955850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1995 |
| Decision Date | February 09, 1996 |
| Days to Decision | 44 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 |