K090783 is an FDA 510(k) clearance for the TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Tuttnauer U.S.A Co, Ltd. (Washington, US). The FDA issued a Cleared decision on August 20, 2009, 150 days after receiving the submission on March 23, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K090783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2009 |
| Decision Date | August 20, 2009 |
| Days to Decision | 150 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 |