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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K930972
Device Name INTRAMEDULLARY SYSTEMS
Applicant
Baumer Ortopedia , Ltd.
Av. Prefeito Antonio Tavares
Leite 381, 13800-000
Mogi Mirim-Sp-Brasil,  BR
Applicant Contact PAULO S IVO
Correspondent
Baumer Ortopedia , Ltd.
Av. Prefeito Antonio Tavares
Leite 381, 13800-000
Mogi Mirim-Sp-Brasil,  BR
Correspondent Contact PAULO S IVO
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/24/1993
Decision Date 03/29/1994
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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