K-number	K212728
Device name	Standard Bougie, 38 Fr. and Hand Pump
Applicant	Standard Bariatrics
Product code	KNT
Device class	Class II
Decision date	Sep 23, 2021
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Standard Bougie, 38 Fr. and Hand Pump

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