Klinly Ultrasonic Tongue Cleaner
FDA 510(k) clearance K181986 · decided 2019-09-06
Clearance details
- K-number
- K181986
- Device name
- Klinly Ultrasonic Tongue Cleaner
- Applicant
- Kea Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-07-25
- Decision date
- 2019-09-06
- Days to decision
- 408 days
- Clearance type
- Traditional
- Product code
- QIA
- Device class
- 1
- Regulation number
- 872.6865
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Kwun Tong, HK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.