The following data is part of a premarket notification filed by Summit Manufacturing, L.l.c. with the FDA for Prostim Reusable Neurostimulation Electrodes.
| Device ID | K052875 |
| 510k Number | K052875 |
| Device Name: | PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | SUMMIT MANUFACTURING, L.L.C. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SUMMIT MANUFACTURING, L.L.C. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-12 |
| Decision Date | 2005-12-27 |
| Summary: | summary |