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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 K972815
Device Name PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
Applicant
Grace Medical, Inc.
7715 HWY. 70, SUITE 109
BARTLETT,  TN  38133
Applicant Contact ANTHONY D PRESCOTT
Correspondent
Grace Medical, Inc.
7715 HWY. 70, SUITE 109
BARTLETT,  TN  38133
Correspondent Contact ANTHONY D PRESCOTT
Regulation Number874.3450
Classification Product Code
ETB  
Subsequent Product Code
ETA  
Date Received07/28/1997
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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