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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, partial ossicular replacement
510(k) Number K080070
Device Name K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
Applicant
Grace Medical, Inc.
8500 WOLF LAKE DR., STE. 110
MEMPHIS,  TN  38133
Applicant Contact JEFF COBB
Correspondent
Grace Medical, Inc.
8500 WOLF LAKE DR., STE. 110
MEMPHIS,  TN  38133
Correspondent Contact JEFF COBB
Regulation Number874.3450
Classification Product Code
ETB  
Date Received01/10/2008
Decision Date 04/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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