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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K800144
Device Name FEMORAL CEMENT RESTRICTOR
Applicant
Biomet, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biomet, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3030
Classification Product Code
JDS  
Date Received01/21/1980
Decision Date 02/19/1980
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
Recalls CDRH Recalls
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