FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇾 Malaysia
Carex Hybrid Personal Lubricant
K Number: K223519
·
Decision Aug 11, 2023
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
230
Applicant Total
1
Review Days
261
Basic Information
- Device Name
- Carex Hybrid Personal Lubricant
- K Number
- K223519
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Karex Industries Sdn. Bhd.
- Date Received
- November 23, 2022
- Decision Date
- August 11, 2023
- 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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