510(k) K181986
- Device
- Klinly Ultrasonic Tongue Cleaner
- Applicant
- KEA Products Ltd
- 510(k) number
- K181986
- Product code
- QIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-06
- Date received
- 2018-07-25
- Regulation
- 872.6865
- Classification name
- Powered Tongue Scraper
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Schmidt
- Address
- 10c, Meyer Ind. Bldg, 2 Chong Yip St. Kwun Tong HK 00000 00000
FDA Registration Numbers#
- 3020393302
- 3031293716
- 3021368823
- 3017685521
- 3033858988
- 3007502533
- 3023855650
- 3024787345
Source Documents#
Legacy Summary#
summary
FDA Review#
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