K895848 is an FDA 510(k) clearance for the PRESSURE STEAM STERILIZERS. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on December 11, 1989, 69 days after receiving the submission on October 3, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K895848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1989 |
| Decision Date | December 11, 1989 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |