FDA.reportPublic FDA data

510(k) K242162

Device
Coconut Hybrid
Applicant
Good Clean Love, Inc.
510(k) number
K242162
Product code
NUC
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-19
Date received
2024-07-24
Regulation
884.5300
Classification name
Lubricant, Personal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Wendy Strgar
Address
207 W 5th Ave. Eugene OR US 97401 97401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K250488Cerynë Intimate CareAnsella Therapeutics2025-12-12
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K243972Plain Water-based LubricantGlobal Protection Corp.2025-08-08
K250142Water-based LubricantGlobal Protection Corp.2025-08-08