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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Semi-Constrained, Cemented
510(k) Number K802460
Device Name HELFET ELBOW PROSTHESIS
Applicant
DEPUY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DEPUY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number888.3160
Classification Product Code
JDB  
Date Received10/08/1980
Decision Date 11/19/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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