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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K142418
Device Name I.T.S. Hand Locking Plates System - HLS
Applicant
I.T.S. GmbH
Autal 28
Lassinitzhoehe/Graz,  AT A-8301
Applicant Contact Al Lippincott
Correspondent
Engineering Consulting Services, Inc.
3150 E. 200th. St.
Prior Lake,  MN  55372
Correspondent Contact Al Lippincott
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KTT  
Date Received08/28/2014
Decision Date 09/26/2014
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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