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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, femoral component, cemented, metal
510(k) Number K761243
Device Name 12-9170 SERIES II TOTAL HIP
Applicant
RICHARDO MANUFACTURING CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARDO MANUFACTURING CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3360
Classification Product Code
JDG  
Date Received12/13/1976
Decision Date 12/16/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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