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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stapler, surgical
510(k) Number K213633
Device Name ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Nathan Anderson
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Road
Blue Ash,  OH  45242
Correspondent Contact Ekta Patel
Regulation Number878.4740
Classification Product Code
GAG  
Date Received11/17/2021
Decision Date 04/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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