Elevate Moisturizing Spray

Saliva, Artificial

ELEVATE ORAL CARE

The following data is part of a premarket notification filed by Elevate Oral Care with the FDA for Elevate Moisturizing Spray.

Pre-market Notification Details

Device IDK150074
510k NumberK150074
Device Name:Elevate Moisturizing Spray
ClassificationSaliva, Artificial
Applicant ELEVATE ORAL CARE 346 PIKE ROAD SUITE 5 West Palm Beach,  FL  33411
ContactSteve Pardue
CorrespondentSteve Pardue
ELEVATE ORAL CARE 346 PIKE ROAD SUITE 5 West Palm Beach,  FL  33411
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-14
Decision Date2015-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858290006635 K150074 000
00858290006666 K150074 000
00858290006741 K150074 000
00858290006710 K150074 000
00858290006703 K150074 000
00858290006871 K150074 000
00858290006895 K150074 000

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