The following data is part of a premarket notification filed by Dongwon Medical Co., Ltd. with the FDA for Dw-1c.
| Device ID | K160761 |
| 510k Number | K160761 |
| Device Name: | DW-1C |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | DONGWON MEDICAL CO., LTD. 201-HO, 35, SAAM-RO 340BEON-GIL GWANGSAN-GU, GWANGJU, KOREA Gwangju, KR 62328 |
| Contact | Gil Haeng Lee |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850046400254 | K160761 | 000 |
| 00850046400117 | K160761 | 000 |
| 00850046400124 | K160761 | 000 |
| 00850046400131 | K160761 | 000 |
| 00850046400148 | K160761 | 000 |
| 00850046400162 | K160761 | 000 |
| 00850046400179 | K160761 | 000 |
| 00850046400193 | K160761 | 000 |
| 00850046400209 | K160761 | 000 |
| 00850046400216 | K160761 | 000 |
| 00850046400223 | K160761 | 000 |
| 00850046400100 | K160761 | 000 |
| 00850046400094 | K160761 | 000 |
| 00850046400261 | K160761 | 000 |
| 00850046400278 | K160761 | 000 |
| 00850046400018 | K160761 | 000 |
| 00850046400025 | K160761 | 000 |
| 00850046400032 | K160761 | 000 |
| 00850046400049 | K160761 | 000 |
| 00850046400056 | K160761 | 000 |
| 00850046400063 | K160761 | 000 |
| 00850046400070 | K160761 | 000 |
| 00850046400087 | K160761 | 000 |
| 00850046400230 | K160761 | 000 |
| 00850046400247 | K160761 | 000 |
| B772DWFB1902 | K160761 | 000 |
| B772SC23G360 | K160761 | 000 |
| B772SC23G390 | K160761 | 000 |
| B772SC26G560 | K160761 | 000 |
| B772SC27G538 | K160761 | 000 |
| B772SC27G550 | K160761 | 000 |
| B772SC29G625 | K160761 | 000 |
| B772DWB2102 | K160761 | 000 |
| B772DWFB1803 | K160761 | 000 |
| B772SS23G338 | K160761 | 000 |
| B772DWFB1901 | K160761 | 000 |
| B772DWFB1802 | K160761 | 000 |
| 00850046400155 | K160761 | 000 |
| 00850046400186 | K160761 | 000 |
| 10850046400008 | K160761 | 000 |
| B772DWA1912 | K160761 | 000 |
| B772DWA1913 | K160761 | 000 |
| B772DWB1903 | K160761 | 000 |
| B772DWB2101 | K160761 | 000 |
| B772DWCB1912 | K160761 | 000 |
| B772DWCB1913 | K160761 | 000 |
| B772DWFB1801 | K160761 | 000 |
| 08800050100000 | K160761 | 000 |