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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 cemented acetabular component)
510(K) Number K842893
Device Name DORR HIP PROSTHESIS, ACETABULAR COMPON
Applicant
CARBOMEDICS, INC.
1300-d east anderson ln.
austin,  TX  78752
Contact thomas l craig
Regulation Number888.3320
Classification Product Code
JDL  
Date Received07/23/1984
Decision Date 11/08/1984
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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