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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, cemented
510(k) Number K873585
Device Name POROUS COATED ACETABULAR CUP
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact MARSHA J STONE
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact MARSHA J STONE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received09/04/1987
Decision Date 10/28/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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