K-number	K210437
Device name	Standard Bougie, 38 Fr.
Applicant	Standard Bariatrics
Product code	KNT
Device class	Class II
Decision date	Jun 29, 2021
Decision	Substantially Equivalent
Regulation	876.5980

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View the full FDA submission: accessdata.fda.gov

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Standard Bougie, 38 Fr.

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