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 |