K-number	K093388
Device name	SMART CAPNOLINE GUARDIAN
Applicant	Oridion Medical 1987 , Ltd.
Product code	CCK
Device class	Class II
Decision date	Mar 4, 2010
Decision	Substantially Equivalent
Regulation	868.1400

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View the full FDA submission: accessdata.fda.gov

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SMART CAPNOLINE GUARDIAN

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