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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K171602
Device Name Williams Cystoscopic Injection Needle
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Rebecca Odulio (Li-chun Liu)
Correspondent
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Rebecca Odulio (Li-chun Liu)
Regulation Number876.1500
Classification Product Code
FBK  
Date Received06/01/2017
Decision Date 07/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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