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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
Original Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
orthopedic division
325 paramount drive
raynham,  MA  02767 -0350
Original Contact john d ferros
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/18/1994
Decision Date 12/21/1994
Decision (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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