K-number	K100850
Device name	COWELL IMPLANT SYSTEM
Applicant	Cowellmedi Co., Ltd.
Product code	DZE
Device class	Class II
Decision date	Dec 20, 2010
Decision	Substantially Equivalent
Regulation	872.3640

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View the full FDA submission: accessdata.fda.gov

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COWELL IMPLANT SYSTEM

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