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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K192697
Device Name Instinct Plus Endoscopic Clipping Device
Applicant
Cook Endoscopy
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Applicant Contact Karthik Pillai
Correspondent
Cook Endoscopy
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Correspondent Contact Karthik Pillai
Regulation Number876.4400
Classification Product Code
PKL  
Date Received09/26/2019
Decision Date 03/05/2020
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
Predetermined Change
Control Plan Authorized		 No
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