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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K142778
Device Name ARROW Reverse Shoulder long keel and short keel glenoid base
Applicant
Fournitures Hospitalieres Industrie
Zi De Kernevez – 6 Rue Nobel
Quimper,  FR 29000
Applicant Contact Patricia Donnard
Correspondent
Fournitures Hospitalieres Industrie
Zi De Kernevez ? 6 Rue Nobel
Quimper,  FR 29000
Correspondent Contact Patricia Donnard
Regulation Number888.3660
Classification Product Code
PHX  
Date Received09/26/2014
Decision Date 03/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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