The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Demetech Demediox Absorbable Surgical Suture.
| Device ID | K181582 |
| 510k Number | K181582 |
| Device Name: | DemeTECH DemeDIOX Absorbable Surgical Suture |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | Demetech Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
| Contact | Linda Hernandez |
| Correspondent | Linda Hernandez Demetech Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-15 |
| Decision Date | 2018-08-27 |
| Summary: | summary |