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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
Recalls CDRH Recalls
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