The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Demediox Barbed Absorbable Surgical Suture.
| Device ID | K191361 |
| 510k Number | K191361 |
| Device Name: | DemeDIOX Barbed Absorbable Surgical Suture |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | DemeTECH Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
| Contact | Tracy Chadwrick |
| Correspondent | Tracy Chadwrick DemeTECH Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-21 |
| Decision Date | 2019-11-07 |