AEON Retrieval Bag

Laparoscope, General & Plastic Surgery

Lexington Medical Inc.

The following data is part of a premarket notification filed by Lexington Medical Inc. with the FDA for Aeon Retrieval Bag.

Pre-market Notification Details

Device IDK180114
510k NumberK180114
Device Name:AEON Retrieval Bag
ClassificationLaparoscope, General & Plastic Surgery
Applicant Lexington Medical Inc. 11 Executive Park Drive Billerica,  MA  01862
ContactDonna Gasper
CorrespondentDonna Gasper
Lexington Medical Inc. 11 Executive Park Drive Billerica,  MA  01862
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-16
Decision Date2018-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851574008783 K180114 000
00851574008745 K180114 000

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