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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 K150568
Device Name ARROW Humeral stems size 6 and 16
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  
Subsequent Product Codes
HSD   KWT  
Date Received03/06/2015
Decision Date 10/29/2015
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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