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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, shoulder, semi-constrained, metal/polymer cemented
510(k) Number K904880
Device Name BUECHEL-PAPPAS HUMERAL STEM COMPONENT
Applicant
ENDOTEC, INC.
20 VALLEY ST.
SOUTH ORANGE,  NJ  07079
Applicant Contact MICHAEL J PAPPAS
Correspondent
ENDOTEC, INC.
20 VALLEY ST.
SOUTH ORANGE,  NJ  07079
Correspondent Contact MICHAEL J PAPPAS
Regulation Number888.3660
Classification Product Code
KWS  
Date Received10/30/1990
Decision Date 01/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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