K962755 is an FDA 510(k) clearance for the STRYKER ENCORE STERILIZER. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on March 4, 1997, 231 days after receiving the submission on July 16, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K962755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1996 |
| Decision Date | March 04, 1997 |
| Days to Decision | 231 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 |