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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 K160521
Device Name ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
Applicant
Ethicon Endo- Surgery., LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Marjorie Medina
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact Kweku Biney
Regulation Number878.4750
Classification Product Code
GDW  
Date Received02/25/2016
Decision Date 03/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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