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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K950010
Device Name DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
ROUTE 202 N.
RARITAN,  NJ  08869
Applicant Contact JOHN D FERROS
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
ROUTE 202 N.
RARITAN,  NJ  08869
Correspondent Contact JOHN D FERROS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/03/1995
Decision Date 05/15/1995
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
Predetermined Change
Control Plan Authorized		 No
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