Name: Predicase
Price: 199 USD

K-number	K022665
Device name	POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
Applicant	Hohenstein Enterprises, Inc.
Product code	KKY
Device class	Class II
Decision date	Oct 9, 2002
Decision	Substantially Equivalent
Regulation	878.3500

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Source

View the full FDA submission: accessdata.fda.gov

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POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE

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