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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 K850352
Device Name MICRO-STRUC. ACETABULAR COMPON- MC2P
Applicant
OSTEONICS CORP.
59 route 17
allendale,  NJ  07401 -1677
Applicant Contact dennis h crane
Correspondent
OSTEONICS CORP.
59 route 17
allendale,  NJ  07401 -1677
Correspodent Contact dennis h crane
Regulation Number888.3320
Classification Product Code
JDL  
Date Received01/28/1985
Decision Date 04/25/1985
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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