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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K082996
FOIA Releasable 510(k) K082996
Device Name BIOLOX DELTA OPTION CERAMIC HEADS
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3353
Classification Product Code
LZO  
Date Received10/08/2008
Decision Date 01/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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