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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 K063374
Device Name NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
Applicant
Grace Medical, Inc.
8500 Wolf Lake Dr.
Suite 110
Memphis,  TN  38133
Applicant Contact JEFF COBB
Correspondent
Grace Medical, Inc.
8500 Wolf Lake Dr.
Suite 110
Memphis,  TN  38133
Correspondent Contact JEFF COBB
Regulation Number874.3450
Classification Product Code
ETB  
Date Received11/08/2006
Decision Date 12/06/2006
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
Predetermined Change
Control Plan Authorized		 No
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