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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K823724
Device Name SPECTRON NECK REPLACEMENT PROSTHESIS
Applicant
Richard'S Medical Equip., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Richard'S Medical Equip., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3350
Classification Product Code
JDI  
Date Received12/10/1982
Decision Date 03/09/1983
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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