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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
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