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 IDK143726
510k NumberK143726
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-29
Decision Date2015-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849405011309 K143726 000
00849405001454 K143726 000
00849405000013 K143726 000
00849405000426 K143726 000
00849405000419 K143726 000
00849405000402 K143726 000
00849405000396 K143726 000
00849405000051 K143726 000

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