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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 K201882
Device Name AEON Endoscopic Stapler
Applicant
Lexington Medical, Inc.
11 Executive Park Dr.
Billerica,  MA  01862
Applicant Contact Rainer Maas
Correspondent
Lexington Medical, Inc.
11 Executive Park Dr.
Billerica,  MA  01862
Correspondent Contact Rainer Maas
Regulation Number878.4750
Classification Product Code
GDW  
Date Received07/08/2020
Decision Date 10/09/2020
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
Predetermined Change
Control Plan Authorized		 No
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