K130123 is an FDA 510(k) clearance for the BASIC AND DOMINANT FLEX SUCTION PUMPS. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Medela AG (Dousman, US). The FDA issued a Cleared decision on October 11, 2013, 267 days after receiving the submission on January 17, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K130123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2013 |
| Decision Date | October 11, 2013 |
| Days to Decision | 267 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 |