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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, personal
510(k) Number K190323
Device Name Aloe Glide Lubricant
Applicant
Desert Harvest, Inc
437 Dimmocks Mill Rd Suite 17b
Hillsborough,  NC  27278
Applicant Contact Heather Florio
Correspondent
Amin Talati Wasserman, LLP
100 S. Wacker Drive, Suite 2000
Chicago,  IL  60606
Correspondent Contact Abhishek Gurnani
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/13/2019
Decision Date 09/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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