The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Silky Ii Polydek, Cottony Ii, Tevdek Ii, Nextstitch, Deklene Ii, Deklene Maxx Gabbay-frater, Nylon, Silk, Stainless Steel.
| Device ID | K153076 |
| 510k Number | K153076 |
| Device Name: | Silky II POLYDEK, Cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAQ |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-23 |
| Decision Date | 2016-06-16 |
| Summary: | summary |