FDA 510(k) Application Details - K011504

Device Classification Name	Nail, Fixation, Bone   More FDA Info for this Device
510(K) Number	K011504
Device Name	Nail, Fixation, Bone
Applicant	BAUMER S.A. AV. PREF. ANTONIO TAVARES LEITE NR: 181 MOGI MIRIM, SAO PAULO 13803-330 BR Other 510(k) Applications for this Company
Contact	BRENO CORREA FARAGO JR. Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2001
Decision Date	08/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review