ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
FDA 510(k) clearance K112217 · decided 2012-10-16
Clearance details
- K-number
- K112217
- Device name
- ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
- Applicant
- Polichem S.A
- Decision
- Substantially Equivalent
- Date received
- 2011-08-02
- Decision date
- 2012-10-16
- Days to decision
- 441 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Jackson, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.