Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

Negative Pressure Wound Therapy Powered Suction Pump

Genadyne Biotechnologies, Inc.

The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Genadyne Uno Plus (uno+) Negative Pressure Wound Therapy System.

Pre-market Notification Details

Device IDK210107
510k NumberK210107
Device Name:Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Genadyne Biotechnologies, Inc. 16 Midland Ave Hicksville,  NY  11801
ContactSaiken Ho
CorrespondentSaiken Ho
Genadyne Biotechnologies, Inc. 16 Midland Ave Hicksville,  NY  11801
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-15
Decision Date2022-06-01

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