FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
K Number: K242645
·
Decision Dec 6, 2024
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
1
Review Days
94
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Basic Information
- Device Name
- INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
- K Number
- K242645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Project Chemistry, Inc.
- Date Received
- September 3, 2024
- Decision Date
- December 6, 2024
- Product Code
- NUC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUC | Lubricant, Personal | FDA class 2 | Obstetrics/Gynecology |
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