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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 K943462
Device Name DARWIN KNEE SYSTEM
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
ORTHOPEDIC DIVISION
325 PARAMOUNT DRIVE
RAYNHAM,  MA  02767 -0350
Applicant Contact JOHN D FERROS
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
ORTHOPEDIC DIVISION
325 PARAMOUNT DRIVE
RAYNHAM,  MA  02767 -0350
Correspondent Contact JOHN D FERROS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/18/1994
Decision Date 12/21/1994
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
Recalls CDRH Recalls
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