The following data is part of a premarket notification filed by Spes Medica S.r.l with the FDA for Ac Cream - Conductive Paste.
Device ID | K212326 |
510k Number | K212326 |
Device Name: | AC Cream - Conductive Paste |
Classification | Media, Electroconductive |
Applicant | Spes Medica S.r.l Via Europa-Zona Industriale Battipaglia, IT 84091 |
Contact | Giorgio Facco |
Correspondent | Giorgio Facco Spes Medica S.r.l Via Europa-Zona Industriale Battipaglia, 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 | 2021-07-26 |
Decision Date | 2021-12-01 |