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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K223300
Device Name Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
Applicant
Geotek Medikal Ltd Sti
Ivedik Osb, Agac Metal Sitesi 1436 Sk. No: 12.
Ankara,  TR 06378
Applicant Contact Latif Iba
Correspondent
Licensale, Inc.
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/27/2022
Decision Date 04/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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