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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, non-constrained, metal/polymer cemented
510(k) Number K032507
Device Name INTERLOK BIO-MODULAR HUMERAL STEMS
Applicant
BIOMET, INC.
56 BELL DR.
PO BOX 587
warsaw,  IN  46581 -0587
Applicant Contact patricia s beres
Correspondent
BIOMET, INC.
56 BELL DR.
PO BOX 587
warsaw,  IN  46581 -0587
Correspondent Contact patricia s beres
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS  
Date Received08/14/2003
Decision Date 09/05/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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