K-number	K183171
Device name	ScopeSeal Duodenoscope Protective Device
Applicant	Gi Scientific, LLC
Product code	ODB
Device class	Class II
Decision date	Oct 8, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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ScopeSeal Duodenoscope Protective Device

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