K041579 is an FDA 510(k) clearance for the MEDELA SINGLE USE SILC CUP, MODEL 077.0791. This device is classified as a Extractor, Vacuum, Fetal (Class II - Special Controls, product code HDB).
Submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on April 21, 2005, 311 days after receiving the submission on June 14, 2004.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4340.
| 510(k) Number | K041579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2004 |
| Decision Date | April 21, 2005 |
| Days to Decision | 311 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDB — Extractor, Vacuum, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4340 |