The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Stimuplex, Nerve Stimulator.
| Device ID | K860126 |
| 510k Number | K860126 |
| Device Name: | STIMUPLEX, NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Tracey Yakabow |
| Correspondent | Tracey Yakabow BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-14 |
| Decision Date | 1986-02-28 |