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FDA 510(k) Application Details - K170741
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K170741
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
GEOTEK Medikal Ltd Sti
Ivedik OSB, Agac Metal Sitesi 1436 Sk. No:12
Ankara 06738 TR
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Contact
Latif Iba
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2017
Decision Date
06/01/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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