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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K013424
Device Name INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
Applicant
Hand Innovations, Inc.
8905 SW 87th Ave.
Miami,  FL  33176 -2227
Applicant Contact AL WEISENBORN
Correspondent
Hand Innovations, Inc.
8905 SW 87th Ave.
Miami,  FL  33176 -2227
Correspondent Contact AL WEISENBORN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received10/15/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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