K-number	K080070
Device name	K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
Applicant	Grace Medical, Inc.
Product code	ETB
Device class	Class II
Decision date	Apr 17, 2008
Decision	Substantially Equivalent
Regulation	874.3450

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View the full FDA submission: accessdata.fda.gov

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K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

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