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 Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/13/2019 |
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
|
|
|