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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, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
510(k) Number K830408
Device Name FREEMAN/SAMUELSON TOTAL KNEE
Applicant
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3560
Classification Product Code
MBV  
Date Received02/07/1983
Decision Date 02/24/1983
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
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