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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
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