K021368 is an FDA 510(k) clearance for the MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Medela AG (Ch-6340 Baar, CH). The FDA issued a Cleared decision on May 15, 2002, 15 days after receiving the submission on April 30, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K021368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2002 |
| Decision Date | May 15, 2002 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |