K151597 is an FDA 510(k) clearance for the Family of Steam Sterilizers B 28 series. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on March 4, 2016, 266 days after receiving the submission on June 12, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K151597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2015 |
| Decision Date | March 04, 2016 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |