K103343 is an FDA 510(k) clearance for the L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT). This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on April 29, 2011, 165 days after receiving the submission on November 15, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K103343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2010 |
| Decision Date | April 29, 2011 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZI - Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |