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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, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K940389
Device Name S.T.E.P. UNI-KNEE
Applicant
S.T.E.P. ORTHOPAEDICS, INC.
711A ABER COURT
WATERFORD,  WI  53185
Applicant Contact STEVEN W BURNS
Correspondent
S.T.E.P. ORTHOPAEDICS, INC.
711A ABER COURT
WATERFORD,  WI  53185
Correspondent Contact STEVEN W BURNS
Regulation Number888.3530
Classification Product Code
HRY  
Date Received01/26/1994
Decision Date 01/19/1995
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
Predetermined Change
Control Plan Authorized		 No
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