Name: Predicase
Price: 199 USD

K-number	K080317
Device name	ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
Applicant	Syntheon, LLC
Product code	FDF
Device class	Class II
Decision date	Apr 29, 2008
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL

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