Name: Predicase
Price: 199 USD

K-number	K090557
Device name	GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
Applicant	Given Imaging , Ltd.
Product code	NSI
Device class	Class II
Decision date	Sep 28, 2009
Decision	Substantially Equivalent
Regulation	876.1300

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Source

View the full FDA submission: accessdata.fda.gov

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GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM

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