K053389 is an FDA 510(k) clearance for the AESCULAP STERILCONTAINER SYSTEM. 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 February 15, 2006, 72 days after receiving the submission on December 5, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K053389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2005 |
| Decision Date | February 15, 2006 |
| Days to Decision | 72 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 |