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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.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
Biomet, Inc.
56 Bell Dr.
P.O. 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
Predetermined Change
Control Plan Authorized		 No
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