K110867 is an FDA 510(k) clearance for the STERI-DENT, STERI-SURE. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Cpac, Inc. (Leicester, US). The FDA issued a Cleared decision on July 20, 2011, 113 days after receiving the submission on March 29, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K110867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2011 |
| Decision Date | July 20, 2011 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |