Genistrong

Laparoscope, General & Plastic Surgery

Genicon, Inc

The following data is part of a premarket notification filed by Genicon, Inc with the FDA for Genistrong.

Pre-market Notification Details

Device IDK180836
510k NumberK180836
Device Name:Genistrong
ClassificationLaparoscope, General & Plastic Surgery
Applicant Genicon, Inc 6869 Stapoint Court Suite 114 Winter Park,  FL  32792
ContactKatlyn Kachman
CorrespondentKatlyn Kachman
Genicon, Inc 6869 Stapoint Court Suite 114 Winter Park,  FL  32792
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-30
Decision Date2018-04-18
Summary:summary

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