The following data is part of a premarket notification filed by Desert Harvest, Inc with the FDA for Aloe Glide Lubricant.
Device ID | K190323 |
510k Number | K190323 |
Device Name: | Aloe Glide Lubricant |
Classification | Lubricant, Personal |
Applicant | Desert Harvest, Inc 437 Dimmocks Mill Rd Suite 17b Hillsborough, NC 27278 |
Contact | Heather Florio |
Correspondent | Abhishek Gurnani Amin Talati Wasserman, LLP 100 S. Wacker Drive, Suite 2000 Chicago, IL 60606 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-13 |
Decision Date | 2019-09-25 |
Summary: | summary |