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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 K250842
Device Name PADLOCK CLIP EFTR Kit (00713229)
Applicant
Steris Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Jackie Oliver
Correspondent
Steris Corporation
5960 Heisley Rd.
Mento,  OH  44060 -1834
Correspondent Contact Gregory Land
Regulation Number876.4400
Classification Product Code
PKL  
Subsequent Product Codes
FDI   KNS   OCZ  
Date Received03/20/2025
Decision Date 04/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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