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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 K905262
Device Name BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH
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 Number888.3350
Classification Product Code
JDI  
Date Received11/23/1990
Decision Date 05/19/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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