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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 K921225
Device Name INTEGRAL TOTAL HIP SYSTEM
Applicant
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA S BERES
Regulation Number888.3353
Classification Product Code
LZO  
Date Received03/13/1992
Decision Date 02/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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