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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 K870234
Device Name P.T.H. METAL-BACKED ACETABULAR CUP
Applicant
ORTHOPAEDIC DEVICE CORP.
6 pearl court
allendale,  NJ  07401
Contact alex khowaylo
Regulation Number888.3320
Classification Product Code
JDL  
Date Received01/21/1987
Decision Date 03/20/1987
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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