K061033 is an FDA 510(k) clearance for the MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS). This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on December 12, 2006, 242 days after receiving the submission on April 14, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K061033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2006 |
| Decision Date | December 12, 2006 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |