Solevy Co. LLC Water-Based Personal Lubricant
FDA 510(k) clearance K203654 · decided 2021-04-19
Clearance details
- K-number
- K203654
- Device name
- Solevy Co. LLC Water-Based Personal Lubricant
- Applicant
- Solevy Co., LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-12-15
- Decision date
- 2021-04-19
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.