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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 K032705
Device Name DISTAL RADIUS FRACTURE REPAIR SYSTEM
Applicant
Hand Innovations, Inc.
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Applicant Contact AL WEISENBORN
Correspondent
Hand Innovations, Inc.
8905 SW 87th Ave.,
Suite 220
Miami Lakes,  FL  33176
Correspondent Contact AL WEISENBORN
Regulation Number888.3030
Classification Product Code
LXT  
Date Received09/02/2003
Decision Date 10/01/2003
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
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