Sage 2-in-1 Personal Lubricant And Moisturizer

Lubricant, Personal

Fairhaven Health, LLC

The following data is part of a premarket notification filed by Fairhaven Health, Llc with the FDA for Sage 2-in-1 Personal Lubricant And Moisturizer.

Pre-market Notification Details

Device IDK190150
510k NumberK190150
Device Name:Sage 2-in-1 Personal Lubricant And Moisturizer
ClassificationLubricant, Personal
Applicant Fairhaven Health, LLC 1410 11th St Bellingham,  WA  98225
ContactSuzanne Munson
CorrespondentSuzanne Munson
Fairhaven Health, LLC 1410 11th St Bellingham,  WA  98225
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-30
Decision Date2019-07-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00896593002503 K190150 000

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