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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 K011504
Device Name BAUMER LOCKING NAIL
Applicant
Baumer, S.A
Av. Pref. Antonio Tavares
Leite Nr: 181
Mogi Mirim, Sao Paulo,  BR 13803-330
Applicant Contact BRENO CORREA FARAGO JR.
Correspondent
Baumer, S.A
Av. Pref. Antonio Tavares
Leite Nr: 181
Mogi Mirim, Sao Paulo,  BR 13803-330
Correspondent Contact BRENO CORREA FARAGO JR.
Regulation Number888.3030
Classification Product Code
JDS  
Subsequent Product Code
HSB  
Date Received05/16/2001
Decision Date 08/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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