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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 K780299
Device Name TOTAL KNEE SYSTEM
Applicant
Richard'S Medical Equip., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Richard'S Medical Equip., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3530
Classification Product Code
HRY  
Date Received02/22/1978
Decision Date 04/27/1978
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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