K023353 is an FDA 510(k) clearance for the SYDNEY IVF HYALURONIDASE. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on December 20, 2002, 74 days after receiving the submission on October 7, 2002.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K023353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2002 |
| Decision Date | December 20, 2002 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |