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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K233079
Device Name Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
Applicant
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park, Plassey
Limerick,  IE V94 N8X2
Applicant Contact Casey Kieran
Correspondent
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park, Plassey
Limerick,  IE V94 N8X2
Correspondent Contact Casey Kieran
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/26/2023
Decision Date 06/14/2024
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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