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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 K915527
Device Name CPS ACETABULAR COMPONENT
Applicant
Implantology Corp.
11 Oak Ln.
Pine Brook,  NJ  07058
Applicant Contact MARK R FORTE
Correspondent
Implantology Corp.
11 Oak Ln.
Pine Brook,  NJ  07058
Correspondent Contact MARK R FORTE
Regulation Number888.3320
Classification Product Code
JDL  
Date Received12/10/1991
Decision Date 06/24/1993
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
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