Next Science Wound Gel (Rx)

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 (rx).

Pre-market Notification Details

Device IDK163188
510k NumberK163188
Device Name:Next Science Wound Gel (Rx)
ClassificationDressing, Wound, Drug
Applicant Next Science, LLC 8130 Baymeadows Way W, Suite 200 Jacksonville,  FL  32256
ContactMatthew Myntti
CorrespondentMatthew Myntti
Next Science, LLC 8130 Baymeadows Way W, Suite 200 Jacksonville,  FL  32256
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-11-14
Decision Date2017-03-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00370858000096 K163188 000
00370858000089 K163188 000
00370858000072 K163188 000
00370858000041 K163188 000
00864076000285 K163188 000
00864076000216 K163188 000

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