The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Hexidis Alcohol Swab.
| Device ID | K910735 |
| 510k Number | K910735 |
| Device Name: | HEXIDIS ALCOHOL SWAB |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
| Product Code | LKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-21 |
| Decision Date | 1991-04-02 |