K043544 is an FDA 510(k) clearance for the MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Medela AG (Baar, CH). The FDA issued a Cleared decision on January 7, 2005, 15 days after receiving the submission on December 23, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K043544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2004 |
| Decision Date | January 07, 2005 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |