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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 K820852
Device Name MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY
Applicant
Serrano Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Serrano Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/26/1982
Decision Date 04/15/1982
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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