K962282 is an FDA 510(k) clearance for the TUTTNAUER PREVACUUM TABLE AUTOCLAVE. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Tuttnauer U.S.A Co, Ltd. (Ronkonkoma, US). The FDA issued a Cleared decision on November 12, 1997, 518 days after receiving the submission on June 12, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K962282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 1996 |
| Decision Date | November 12, 1997 |
| Days to Decision | 518 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 |