K895164 is an FDA 510(k) clearance for the EAGLE DS. This device is classified as a Sterilizer, Boiling Water (Class I - General Controls, product code ECG).
Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on November 17, 1989, 87 days after receiving the submission on August 22, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6710.
| 510(k) Number | K895164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1989 |
| Decision Date | November 17, 1989 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ECG — Sterilizer, Boiling Water |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6710 |