The following data is part of a premarket notification filed by Bioness Inc. with the FDA for L300 Plus System (right, Left), L300 Plus System Upgrade Kit (right, Left).
| Device ID | K103343 |
| 510k Number | K103343 |
| Device Name: | L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | BIONESS INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Contact | Adele Shoustal |
| Correspondent | Adele Shoustal BIONESS INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-15 |
| Decision Date | 2011-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110483043 | K103343 | 000 |
| 07290110483036 | K103343 | 000 |
| 07290110483029 | K103343 | 000 |
| 07290110483012 | K103343 | 000 |
| 07290110483005 | K103343 | 000 |