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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
Recalls CDRH Recalls
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