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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 K924141
Device Name ORTHOPAEDIC POLYETHYLENE CABLE
Applicant
Smith & Nephew Richards, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
Smith & Nephew Richards, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received08/18/1992
Decision Date 11/30/1993
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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