K-number	K210419
Device name	BIOTEQ Drainage Catheter BT-PDS-series
Applicant	Bioteque Corporation
Product code	FGE
Device class	Class II
Decision date	Apr 13, 2022
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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BIOTEQ Drainage Catheter BT-PDS-series

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