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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 K871608
Device Name RODRIGUEZ NAIL
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 Number888.3020
Classification Product Code
HSB  
Date Received04/24/1987
Decision Date 05/08/1987
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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