HANAROSTENT Esophagus Asymmetric (CCC)

Prosthesis, Esophageal

M.I.Tech Co., Ltd.

The following data is part of a premarket notification filed by M.i.tech Co., Ltd. with the FDA for Hanarostent Esophagus Asymmetric (ccc).

Pre-market Notification Details

Device IDK213251
510k NumberK213251
Device Name:HANAROSTENT Esophagus Asymmetric (CCC)
ClassificationProsthesis, Esophageal
Applicant M.I.Tech Co., Ltd. 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si,  KR 17706
ContactSunyoung Jo
CorrespondentHeidi Busz
Namsa 00 Highway 169 South, Suite 500 Minneapolis,  MN  55426
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2021-11-18

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