K954142 is an FDA 510(k) clearance for the STERRADD STERILIZATION SYSTEM. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on June 6, 1997, 644 days after receiving the submission on September 1, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K954142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1995 |
| Decision Date | June 06, 1997 |
| Days to Decision | 644 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 |