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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 K990830
Device Name MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
Applicant
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/12/1999
Decision Date 04/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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