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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 K942809
Device Name ACETABULAR DOME HOLE PLUGS
Applicant
OSTEONICS CORP.
59 route 17
allendale,  NJ  07401 1677
Contact robert a koch, j.d.
Regulation Number888.3320
Classification Product Code
JDL  
Date Received06/14/1994
Decision Date 09/20/1994
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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