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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K954186
Device Name SLED UNICOMPARTMENT KNEE SYSTEM
Applicant
LINK AMERICA, INC.
C/O SURGICAL IMPLANTS, INC.
10 GREAT MEADOW LANE
EAST HANAVOR,  NJ  07936
Applicant Contact DOUGLAS STUART
Correspondent
LINK AMERICA, INC.
C/O SURGICAL IMPLANTS, INC.
10 GREAT MEADOW LANE
EAST HANAVOR,  NJ  07936
Correspondent Contact DOUGLAS STUART
Regulation Number888.3520
Classification Product Code
HSX  
Date Received09/06/1995
Decision Date 01/26/1996
Decision Substantially Equivalent (SESE)
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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