Name: Predicase
Price: 199 USD

K-number	K103088
Device name	GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
Applicant	Given Imaging , Ltd.
Product code	NEZ
Device class	Class II
Decision date	Jan 14, 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 PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

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