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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 K183435
Device Name Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C Suite 202
Guaynabo,  PR  00969
Applicant Contact Sigfrido Delgado
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45245
Correspondent Contact Brian Ruble
Regulation Number878.4750
Classification Product Code
GDW  
Date Received12/11/2018
Decision Date 02/06/2019
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
Predetermined Change
Control Plan Authorized		 No
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