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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K180114
Device Name AEON Retrieval Bag
Applicant
Lexington Medical, Inc.
11 Executive Park Dr.
Billerica,  MA  01862
Applicant Contact Donna Gasper
Correspondent
Lexington Medical, Inc.
11 Executive Park Dr.
Billerica,  MA  01862
Correspondent Contact Donna Gasper
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/16/2018
Decision Date 03/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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