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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, Cemented
510(k) Number K001571
Device Name BAUMER FEMORAL HEAD
Applicant
Baumer, S.A
Av. Pref. Antonio Tavares
Leite Nr: 181
Mogi Mirim, Sao Paulo,  BR 13803-330
Applicant Contact BRENO C FARAGO, JR.
Correspondent
Baumer, S.A
Av. Pref. Antonio Tavares
Leite Nr: 181
Mogi Mirim, Sao Paulo,  BR 13803-330
Correspondent Contact BRENO C FARAGO, JR.
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
KWL  
Date Received05/22/2000
Decision Date 08/04/2000
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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