Name: Predicase
Price: 199 USD

K-number	K091962
Device name	POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
Applicant	Lumenis, Inc.
Product code	ODF
Device class	Class II
Decision date	Sep 30, 2009
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200

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