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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K150503
Device Name Echo Bi-Metric Microplasty Line Extension
Applicant
BIOMET, INC.
56 EAST BELL DRIVE
WARSAW,  IN  46581
Applicant Contact AMY WALRIVEN
Correspondent
BIOMET, INC.
56 EAST BELL DRIVE
WARSAW,  IN  46581
Correspondent Contact AMY WALRIVEN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LWJ  
LZO   OQG   OQH   OQI   PBI  
Date Received02/26/2015
Decision Date 03/25/2015
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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