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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, shoulder, humeral (bipolar hemi-shoulder) metal/polymer, cemented or uncemented
510(k) Number K960363
Device Name BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581
Applicant Contact PATRICIA S BERES
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581
Correspondent Contact PATRICIA S BERES
Classification Product Code
MJT  
Subsequent Product Code
KWT  
Date Received01/25/1996
Decision Date 02/18/1997
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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