K-number	K230328
Device name	Speedboat Flush SB1 Instrument
Applicant	Creo Medical, Ltd.
Product code	KNS
Device class	Class II
Decision date	Oct 31, 2023
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Speedboat Flush SB1 Instrument

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