The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Demetech Demeforce Nonabsorbable Surgical Suture.
| Device ID | K190777 |
| 510k Number | K190777 |
| Device Name: | DemeTECH DemeFORCE Nonabsorbable Surgical Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-26 |
| Decision Date | 2019-07-31 |
| Summary: | summary |