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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 Terrace
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
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