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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 K875156
Device Name STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM
Applicant
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received12/15/1987
Decision Date 01/20/1988
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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