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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/Polymer, Porous Uncemented
510(k) Number K955511
Device Name ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
Applicant
Joint Medical Products Corp.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact JOHN D FERROS
Correspondent
Joint Medical Products Corp.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact JOHN D FERROS
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received12/04/1995
Decision Date 02/26/1996
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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