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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, Femoral Component, Cemented, Metal
510(k) Number K955171
Device Name NEXLOCK FEMORAL STEM
Applicant
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211 -5148
Applicant Contact REBECCA H WAHL
Correspondent
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211 -5148
Correspondent Contact REBECCA H WAHL
Regulation Number888.3360
Classification Product Code
JDG  
Date Received11/13/1995
Decision Date 02/09/1996
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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