Next Science Wound Gel

Dressing, Wound, Drug

NEXT SCIENCE, LLC

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

Pre-market Notification Details

Device IDK150792
510k NumberK150792
Device Name:Next Science Wound Gel
ClassificationDressing, Wound, Drug
Applicant NEXT SCIENCE, LLC 8130 BAYMEADOWS WAY WEST, SUITE 200 Jacksonville,  FL  33256
ContactMatthew Myntti
CorrespondentMatthew Myntti
NEXT SCIENCE, LLC 8130 BAYMEADOWS WAY WEST, SUITE 200 Jacksonville,  FL  33256
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2015-03-25
Decision Date2015-12-17
Summary:summary

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