MINT Product Family

Suture, Surgical, Absorbable, Polydioxanone

Hans Biomed Corporation

The following data is part of a premarket notification filed by Hans Biomed Corporation with the FDA for Mint Product Family.

Pre-market Notification Details

Device IDK192423
510k NumberK192423
Device Name:MINT Product Family
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant Hans Biomed Corporation 7, Jeongui-ro 8-gil, Songpa-gu Seoul,  KR 05836
ContactLucy Choi
CorrespondentMichael Dun
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin,  TX  78746
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-04
Decision Date2020-09-09

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