HANAROSTENT Trachea/Bronchium (CCC)

Prosthesis, Tracheal, Expandable

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 Trachea/bronchium (ccc).

Pre-market Notification Details

Device IDK201342
510k NumberK201342
Device Name:HANAROSTENT Trachea/Bronchium (CCC)
ClassificationProsthesis, Tracheal, Expandable
Applicant M.I. Tech Co., Ltd. 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si,  KR 17706
ContactInae Kim
CorrespondentBeryl St. Jeanne
NAMSA 400 Highway 169 South, Suite 500 Minneapolis,  MN  55426
Product CodeJCT  
CFR Regulation Number878.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-12-31

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