K093493 is an FDA 510(k) clearance for the AESCULAP STERILCONTAINER S. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 27, 2010, 259 days after receiving the submission on November 10, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K093493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2009 |
| Decision Date | July 27, 2010 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |