K973550 is an FDA 510(k) clearance for the TUTTNAUER TABLE-TOP 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 D.C., US). The FDA issued a Cleared decision on October 29, 1997, 41 days after receiving the submission on September 18, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K973550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1997 |
| Decision Date | October 29, 1997 |
| Days to Decision | 41 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 |