XLR8 PLUS (XLR8+)

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 Xlr8 Plus (xlr8+).

Pre-market Notification Details

Device IDK141437
510k NumberK141437
Device Name:XLR8 PLUS (XLR8+)
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville,  NY  11801
ContactChien Ming, Goh
CorrespondentChien Ming, Goh
GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville,  NY  11801
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-30
Decision Date2014-09-19
Summary:summary

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