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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 K933340
Device Name OSTEO INTERLOCKING-COMPRESSION NAIL
Applicant
Osteo AG
208 Dublin Rd.
Greenwood,  SC 
Applicant Contact FRED C BRYSON, JR.
Correspondent
Osteo AG
208 Dublin Rd.
Greenwood,  SC 
Correspondent Contact FRED C BRYSON, JR.
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/08/1993
Decision Date 06/30/1994
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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