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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 K150026
Device Name Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
Applicant
ETHICON ENDO-SURGERY, LLC
475 CALLE C
GUAYNABO,  PR 00969
Applicant Contact Marjorie Medina
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact Christina Canter
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/07/2015
Decision Date 05/18/2015
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
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