Smile Makers Personal Lubricant
FDA 510(k) clearance K182100 · decided 2019-04-25
Clearance details
- K-number
- K182100
- Device name
- Smile Makers Personal Lubricant
- Applicant
- Lfbeauty (Thailand) Limited
- Decision
- Substantially Equivalent
- Date received
- 2018-08-03
- Decision date
- 2019-04-25
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Lamlukka, TH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.