Bactisure Wound Lavage

Lavage, Jet

Next Science, LLC

The following data is part of a premarket notification filed by Next Science, Llc with the FDA for Bactisure Wound Lavage.

Pre-market Notification Details

Device IDK192349
510k NumberK192349
Device Name:Bactisure Wound Lavage
ClassificationLavage, Jet
Applicant Next Science, LLC 10550 Deerwood Park Blvd., Ste. 300 Jacksonville,  FL  32256
ContactJeanne Lee
CorrespondentJeanne Lee
Next Science, LLC 10550 Deerwood Park Blvd., Ste. 300 Jacksonville,  FL  32256
Product CodeFQH  
CFR Regulation Number880.5475 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-08-29
Decision Date2020-01-23

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