K945117 is an FDA 510(k) clearance for the DELTA. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Pelton & Crane Co. (Charlotte, US). The FDA issued a Cleared decision on February 28, 1997, 864 days after receiving the submission on October 18, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K945117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1994 |
| Decision Date | February 28, 1997 |
| Days to Decision | 864 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |