510(k) K123695
- Device
- TRAUS SIP10
- Applicant
- SAESHIN PRECISION CO., LTD.
- 510(k) number
- K123695
- Product code
- EKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-18
- Date received
- 2012-12-03
- Regulation
- 872.4200
- Classification name
- Handpiece, Water-powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Y.S. LEE
- Address
- #93-15, Paho-Dong, Dalseo-Gu Daegu KR 704-220 704-220
FDA Registration Numbers#
- 3007126709
- 3007958831
- 3017604
Source Documents#
Other 510(k) Records For Product Code EKY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896364 | DECIDENT | Nevin Laboratories, Inc. | 1990-07-19 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases