BIOTEQ Drainage Catheter Set (One Step Type)

Stents, Drains And Dilators For The Biliary Ducts

Bioteque Corporation

The following data is part of a premarket notification filed by Bioteque Corporation with the FDA for Bioteq Drainage Catheter Set (one Step Type).

Pre-market Notification Details

Device IDK200103
510k NumberK200103
Device Name:BIOTEQ Drainage Catheter Set (One Step Type)
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant Bioteque Corporation 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City,  TW 10441
ContactStella Hsu
CorrespondentStella Hsu
Bioteque Corporation 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City,  TW 10441
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-17
Decision Date2020-10-09

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