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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 K173443
Device Name AEON Endoscopic Stapler
Applicant
Lexington Medical Inc.
11 Executive Park Drive
Billerica,  MA  01862
Applicant Contact Donna Gasper
Correspondent
Lexington Medical Inc.
11 Executive Park Drive
Billerica,  MA  01862
Correspondent Contact Donna Gasper
Regulation Number878.4750
Classification Product Code
GDW  
Date Received11/06/2017
Decision Date 02/01/2018
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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