The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demetech Silk Nonabsorbable Suture.
| Device ID | K023029 |
| 510k Number | K023029 |
| Device Name: | DEMETECH SILK NONABSORBABLE SUTURE |
| Classification | Suture, Nonabsorbable, Silk |
| 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 | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2002-11-25 |
| Summary: | summary |