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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K082754
Device Name AEQUALIS HUMERAL NAIL SYSTEM
Applicant
TORNIER
100 CAPITAL DRIVE
SUITE 201
WARSAW,  IN  46582
Applicant Contact BRIAN HODOREK
Correspondent
TORNIER
100 CAPITAL DRIVE
SUITE 201
WARSAW,  IN  46582
Correspondent Contact BRIAN HODOREK
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/19/2008
Decision Date 01/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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