K062801 is an FDA 510(k) clearance for the SMARTSUCTION SOLO DEVICE, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on October 4, 2006, 15 days after receiving the submission on September 19, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K062801 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2006 |
| Decision Date | October 04, 2006 |
| 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 |