The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demetech Nylon Nonabsorbable Suture.
| Device ID | K023028 |
| 510k Number | K023028 |
| Device Name: | DEMETECH NYLON NONABSORBABLE SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | DEMETECH CORP. 12119 SW 131 AVE. Miami, FL 33186 |
| Contact | Luis Arguello |
| Correspondent | Luis Arguello DEMETECH CORP. 12119 SW 131 AVE. Miami, FL 33186 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2003-06-18 |
| Summary: | summary |