Data / Medical devices / South Korea / PICOPACK Inc.
PICOPACK Inc.: FDA-registered device maker in Daejeon, South Korea, 2 510(k) clearances
PICOPACK Inc. is registered with the FDA (registration 3029916103) in Daejeon, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029916103
- Address
- Rm.201, 101, 102, 105, 106, 91, Sinilseo-ro 85beon-gil, Daedeok-gu, Daejeon, South Korea, 34325
- Owner or operator
- PICOPACK Inc. (10088890)
- Roles
- Manufacturer
- First device listed
- October 18, 2023
- Registered through
- 2026
- Brand names listed
- MDP, WeRay, WeSensor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 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 |
|---|---|---|---|---|---|---|
| July 30, 2024 | K241963 | WERAY | EHD | Substantially Equivalent | Picopack Co., Ltd. | accessdata.fda.gov |
| October 10, 2023 | K230916 | WeSensor | MUH | Substantially Equivalent | Picopack, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of System, X-Ray, Extraoral Source, Digital
Updated July 30, 2024. 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.