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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K914374
Device Name OSTEO CERCLAGE WIRE
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 Number888.3010
Classification Product Code
JDQ  
Date Received10/01/1991
Decision Date 12/30/1991
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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