K-number	K123151
Device name	ENDOSEE MODEL 8000 U-SCOPE
Applicant	Endosee Corp
Product code	HIH
Device class	Class II
Decision date	Mar 8, 2013
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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ENDOSEE MODEL 8000 U-SCOPE

Everything you need for a 510(k) submission. Nothing you don't.