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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K011531
Device Name CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact DALENE T BINKLEY
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/17/2001
Decision Date 09/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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