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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K003493
Device Name 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
Applicant
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact SARA A BAILEY
Correspondent
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact SARA A BAILEY
Regulation Number872.3930
Classification Product Code
LYC  
Date Received11/13/2000
Decision Date 02/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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