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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, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K800894
Device Name DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
Applicant
Depuy, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Depuy, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3350
Classification Product Code
JDI  
Date Received04/18/1980
Decision Date 05/02/1980
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
Recalls CDRH Recalls
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