Name: Predicase
Price: 199 USD

K-number	K090851
Device name	DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
Applicant	Byrne Medical, Inc.
Product code	ODC
Device class	Class II
Decision date	Jul 2, 2009
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)

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