The following data is part of a premarket notification filed by Spes Medica S.r.l. with the FDA for Sac2 - Electrode Cream.
| Device ID | K192606 |
| 510k Number | K192606 |
| Device Name: | SAC2 - Electrode Cream |
| Classification | Media, Electroconductive |
| Applicant | Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa), IT 84091 |
| Contact | Giogio Facco |
| Correspondent | Giorgio Facco Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa), IT 84091 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2020-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054655027157 | K192606 | 000 |