K041623 is an FDA 510(k) clearance for the REUSABLE STERILCONTAINER FILTER MODEL #JK090. 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 December 13, 2004, 180 days after receiving the submission on June 16, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K041623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2004 |
| Decision Date | December 13, 2004 |
| Days to Decision | 180 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 |