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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K170741
Device Name GTK Disposable Needle Guides
Applicant
Geotek Medikal Ltd Sti
Ivedik Osb, Agac Metal Sitesi 1436 Sk. No:12
Ankara,  TR 06738
Applicant Contact Latif Iba
Correspondent
Licensale, Inc.
68 Southwoods Ter.
Southbury,  CT  06488
Correspondent Contact Raymond Kelly
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/10/2017
Decision Date 06/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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