Aloe Glide Lubricant

Lubricant, Personal

Desert Harvest, Inc

The following data is part of a premarket notification filed by Desert Harvest, Inc with the FDA for Aloe Glide Lubricant.

Pre-market Notification Details

Device IDK190323
510k NumberK190323
Device Name:Aloe Glide Lubricant
ClassificationLubricant, Personal
Applicant Desert Harvest, Inc 437 Dimmocks Mill Rd Suite 17b Hillsborough,  NC  27278
ContactHeather Florio
CorrespondentAbhishek Gurnani
Amin Talati Wasserman, LLP 100 S. Wacker Drive, Suite 2000 Chicago,  IL  60606
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-13
Decision Date2019-09-25
Summary:summary

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