The following data is part of a premarket notification filed by Hans Biomed Corporation with the FDA for Mint Product Family.
| Device ID | K192423 |
| 510k Number | K192423 |
| Device Name: | MINT Product Family |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | Hans Biomed Corporation 7, Jeongui-ro 8-gil, Songpa-gu Seoul, KR 05836 |
| Contact | Lucy Choi |
| Correspondent | Michael Dun Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-09-09 |