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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
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