The following data is part of a premarket notification filed by Salumedica, L.l.c. with the FDA for Salutunnel Nerve Protector, Model Ed-20329, Ed-20330, Ed-20331.
| Device ID | K100382 |
| 510k Number | K100382 |
| Device Name: | SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 |
| Classification | Cuff, Nerve |
| Applicant | SALUMEDICA, L.L.C. 931 E PONCE DE LEON AVE Atlanta, GA 30306 |
| Contact | Bob Braden |
| Correspondent | Bob Braden SALUMEDICA, L.L.C. 931 E PONCE DE LEON AVE Atlanta, GA 30306 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-08-05 |
| Summary: | summary |