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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 K991394
Device Name STAPES PROSTHESES
Applicant
Grace Medical, Inc.
7731 Hwy. 70, Suite 107
Bartlett,  TN  38133
Applicant Contact ANTHONY D PRESCOTT
Correspondent
Grace Medical, Inc.
7731 Hwy. 70, Suite 107
Bartlett,  TN  38133
Correspondent Contact ANTHONY D PRESCOTT
Regulation Number874.3450
Classification Product Code
ETB  
Date Received04/21/1999
Decision Date 05/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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