Esophageal TTS Stent

Prosthesis, Esophageal

Taewoong Medical Co., Ltd

The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Esophageal Tts Stent.

Pre-market Notification Details

Device IDK211706
510k NumberK211706
Device Name:Esophageal TTS Stent
ClassificationProsthesis, Esophageal
Applicant Taewoong Medical Co., Ltd 14 Gojeong-ro, Wolgot-myeon Gimpo-si,  KR 10022
ContactJennifer Moyer
CorrespondentJennifer Moyer
Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-03
Decision Date2021-10-08

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