The following data is part of a premarket notification filed by Bioness Inc. with the FDA for L300 Go System.
| Device ID | K162407 |
| 510k Number | K162407 |
| Device Name: | L300 Go System |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | BIONESS INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Contact | Mercedes Bayani |
| Correspondent | Evan L. Rosenfeld MDJD CONSULTING 5905 WARM MIST LN. Dallas, TX 75248 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-29 |
| Decision Date | 2017-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815962020191 | K162407 | 000 |
| 00815962020184 | K162407 | 000 |
| 00815962020177 | K162407 | 000 |
| 00815962020160 | K162407 | 000 |
| 00815962020153 | K162407 | 000 |
| 00815962020146 | K162407 | 000 |
| 00815962020139 | K162407 | 000 |
| 00815962020115 | K162407 | 000 |
| 00815962020061 | K162407 | 000 |