K823902 is an FDA 510(k) clearance for the EAGLE STERISET. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by American Sterilizer Co. (Walker, US). The FDA issued a Cleared decision on January 9, 1983, 10 days after receiving the submission on December 30, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K823902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1982 |
| Decision Date | January 09, 1983 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |