K920930 is an FDA 510(k) clearance for the MDT/CASTLE 10/90 DUAL LOAD STATION. This device is classified as a Sterilizer, Ethylene-oxide Gas (Class II - Special Controls, product code FLF).
Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on March 31, 1993, 397 days after receiving the submission on February 28, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.
| 510(k) Number | K920930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1992 |
| Decision Date | March 31, 1993 |
| Days to Decision | 397 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLF — Sterilizer, Ethylene-oxide Gas |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6860 |