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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, implantable
510(k) Number K200420
Device Name Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Nathan Anderson
Ethicon Endo-Surgery, Inc.
4545 Creek Rd
Cincinnati,  OH  45252
Correspondent Contact Ruth James
Regulation Number878.4750
Classification Product Code
Date Received02/20/2020
Decision Date 06/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No