The following data is part of a premarket notification filed by Salumedica, L.l.c. with the FDA for Salumedica Nerve Cuff.
| Device ID | K002098 |
| 510k Number | K002098 |
| Device Name: | SALUMEDICA NERVE CUFF |
| Classification | Cuff, Nerve |
| Applicant | SALUMEDICA, L.L.C. 112 KROG ST. SUITE 4 Atlanta, GA 30307 |
| Contact | David N Ku |
| Correspondent | David N Ku SALUMEDICA, L.L.C. 112 KROG ST. SUITE 4 Atlanta, GA 30307 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-11 |
| Decision Date | 2000-11-24 |
| Summary: | summary |