BioNourish Lubricant

Lubricant, Personal

Good Clean Love, Inc.

The following data is part of a premarket notification filed by Good Clean Love, Inc. with the FDA for Bionourish Lubricant.

Pre-market Notification Details

Device IDK193448
510k NumberK193448
Device Name:BioNourish Lubricant
ClassificationLubricant, Personal
Applicant Good Clean Love, Inc. 207 W 5th Avenue Eugene,  OR  97401
ContactWeny Strgar
CorrespondentAbhishek Gurnani
Amin Talati Wasserman, LLP 100 S Wacker Drive, Suite 2000 Chicago,  IL  60606
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-13
Decision Date2020-03-12

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