K052650 is an FDA 510(k) clearance for the PIONEER U601 SERIES ASPIRATOR. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on November 4, 2005, 39 days after receiving the submission on September 26, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K052650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2005 |
| Decision Date | November 04, 2005 |
| Days to Decision | 39 days |
| Submission Type | Abbreviated |
| 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 |