UNO 30

Negative Pressure Wound Therapy Powered Suction Pump

Genadyne Biotechnologies

The following data is part of a premarket notification filed by Genadyne Biotechnologies with the FDA for Uno 30.

Pre-market Notification Details

Device IDK190028
510k NumberK190028
Device Name:UNO 30
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Genadyne Biotechnologies 16 Midland Ave Hicksville,  NY  11801
ContactAndrew Goh
CorrespondentSwara Vashi
Genadyne Biotechnologies 16 Midland Ave Hicksville,  NY  11801
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-07
Decision Date2020-01-15

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