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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 K922196
Device Name OSTEO TIBIA NAIL
Applicant
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Applicant Contact BRYSON, JR.
Correspondent
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Correspondent Contact BRYSON, JR.
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/11/1992
Decision Date 07/23/1992
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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