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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K050932
Device Name DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
Applicant
Hand Innovations, Inc.
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Applicant Contact ERNIE HERNANDEZ
Correspondent
Hand Innovations, Inc.
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Correspondent Contact ERNIE HERNANDEZ
Regulation Number888.3030
Classification Product Code
LXT  
Date Received04/14/2005
Decision Date 04/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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