Data / Medical devices / South Korea / Lemon Co., Ltd
Lemon Co., Ltd: FDA-registered device maker in Gumi-si Gyeongbuk, South Korea, 1 510(k) clearance
Lemon Co., Ltd is registered with the FDA (registration 3015136704) in Gumi-si Gyeongbuk, South Korea. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015136704
- Address
- 1105-65, Sanho-daero, Sandong-eup, Gumi-si Gyeongbuk, South Korea, 39170
- Owner or operator
- LEMON Co., Ltd (10092675)
- Roles
- Manufacturer
- First device listed
- February 5, 2025
- Registered through
- 2026
- Brand names listed
- AIR QUEEN ARBOR LONG PANTY LINER, AIR QUEEN ARBOR ULTRA SLIM LARGE, AIR QUEEN ARBOR LONG PANTY LINER, AIR QUEEN ARBOR ULTRA SLIM LARGE,, AIR QUEEN ARBOR ULTRA SLIM MEDIUM, AIR QUEEN NEW BREATH LARGE SLIM, AIR QUEEN BREEZE; TECHNOWEB, AIR QUEEN ESSENTIAL LARGE, AIR QUEEN ESSENTIAL MEDIUM, AIR QUEEN ESSENTIAL MASK, AIR QUEEN ESSENTIAL OVERNIGHT, AIR QUEEN ESSENTIAL PANTY LINER LONG, AIR QUEEN NEW BREATH MEDIUM SLIM, AIR QUEEN NEW BREATH OVERNIGHT SLIM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy | QOZ | N | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Table, Obstetrical, Ac-Powered (And Accessories) | HDD | 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 |
|---|---|---|---|---|---|---|
| March 1, 2018 | K172500 | Technoweb Surgical Mask | FXX | Substantially Equivalent | Yts Global, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy
- All makers of Table, Obstetrical, Ac-Powered (And Accessories)
- All makers of Pad, Menstrual, Unscented
- All makers of Mask, Surgical
Updated March 1, 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.