Data / Medical devices / South Korea / HRS Co., Ltd.
HRS Co., Ltd.: FDA-registered device maker in Pyongtaek Gyeonggi, South Korea, 2 510(k) clearances
HRS Co., Ltd. is registered with the FDA (registration 3008895253) in Pyongtaek Gyeonggi, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 28, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008895253
- FEI number
- 3008957253
- Address
- 7, Chupalsandan 2-gil Paengseong-eup, Pyongtaek Gyeonggi, South Korea, 17998
- Owner or operator
- HRS Co., Ltd. (10035700)
- Roles
- Manufacturer
- First device listed
- December 10, 2014
- Registered through
- 2026
- Brand names listed
- SILDENT HEAVY BODY, SILDENT LIGHT BODY, SILDENT PUTTY, SILDENT REGULAR BODY, Sildent Bite, Sildent Fast Heavy Body, Sildent Fast Light Body
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 28, 2018 | K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | ELW | Substantially Equivalent | Hrs Co., Ltd. | accessdata.fda.gov |
| June 19, 2014 | K132869 | SILDENT | ELW | Substantially Equivalent | Hrs Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 28, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.