The following data is part of a premarket notification filed by Sm Eng Co., Ltd with the FDA for Rexlene.
| Device ID | K173747 |
| 510k Number | K173747 |
| Device Name: | REXLENE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | SM ENG CO., LTD 46, Nakdong-daero 1302beon-gil Sasang-gu, KR 46910 |
| Contact | Soon-gu Lee |
| Correspondent | Sanglok Lee Wise Company Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-gu, KR 08301 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-08 |
| Decision Date | 2018-12-21 |
| Summary: | summary |