The following data is part of a premarket notification filed by Sm Eng Co., Ltd with the FDA for Rexlon, Rexsil.
| Device ID | K161633 |
| 510k Number | K161633 |
| Device Name: | REXLON, REXSIL |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | SM ENG CO., LTD 46, NAKDONG-DAERO 1302BEON-GIL Sasang-gu, KR |
| Contact | Soon-gu Lee |
| Correspondent | Sanglok Lee WISE COMPANY INC. #306, 3 DAERIM-RO 27GA-GIL Yeongdeungpo-gu, KR 07413 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2017-03-02 |
| Summary: | summary |