The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Tevdek Ii, Silky Ii Polydek, 'cottony' Ii, Nextstitch.
| Device ID | K192490 |
| 510k Number | K192490 |
| Device Name: | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Robin Haden |
| Correspondent | Robin Haden Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-11 |
| Decision Date | 2020-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704670523 | K192490 | 000 |
| 24026704724622 | K192490 | 000 |
| 24026704724615 | K192490 | 000 |
| 24026704724608 | K192490 | 000 |
| 24026704724578 | K192490 | 000 |
| 24026704724561 | K192490 | 000 |
| 24026704724547 | K192490 | 000 |
| 24026704724509 | K192490 | 000 |
| 24026704724493 | K192490 | 000 |
| 24026704724400 | K192490 | 000 |
| 24026704724387 | K192490 | 000 |
| 24026704723922 | K192490 | 000 |
| 24026704723908 | K192490 | 000 |
| 24026704723816 | K192490 | 000 |
| 24026704723762 | K192490 | 000 |
| 00854629006857 | K192490 | 000 |
| 00854629006840 | K192490 | 000 |
| 24026704924060 | K192490 | 000 |
| 24026704724646 | K192490 | 000 |
| 24026704724684 | K192490 | 000 |
| 24026704670448 | K192490 | 000 |
| 24026704647860 | K192490 | 000 |
| 34026704427445 | K192490 | 000 |
| 34026704426363 | K192490 | 000 |
| 34026704427452 | K192490 | 000 |
| 24026704725117 | K192490 | 000 |
| 24026704724936 | K192490 | 000 |
| 24026704724929 | K192490 | 000 |
| 24026704724851 | K192490 | 000 |
| 24026704724837 | K192490 | 000 |
| 24026704723878 | K192490 | 000 |
| 24026704724899 | K192490 | 000 |
| 24026704724820 | K192490 | 000 |
| 24026704724769 | K192490 | 000 |
| 24026704724752 | K192490 | 000 |
| 24026704724738 | K192490 | 000 |
| 24026704724721 | K192490 | 000 |
| 24026704924039 | K192490 | 000 |