The following data is part of a premarket notification filed by Teleflex Medical, Inc with the FDA for Silk Surgical Suture.
| Device ID | K162396 |
| 510k Number | K162396 |
| Device Name: | SILK Surgical Suture |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | TELEFLEX MEDICAL, INC 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Contact | Natalie Hichak |
| Correspondent | Natalie Hichak TELEFLEX MEDICAL, INC 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2016-11-23 |
| Summary: | summary |