Name: Predicase
Price: 199 USD

K-number	K103025
Device name	GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
Applicant	Given Imaging , Ltd.
Product code	NEZ
Device class	Class II
Decision date	May 13, 2011
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 WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

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