Data / Medical devices / Japan / DR. Japan Co., Ltd.
DR. Japan Co., Ltd.: FDA-registered device maker in Gyoda City Saitama, Japan, 1 510(k) clearance
DR. Japan Co., Ltd. is registered with the FDA (registration 9614709) in Gyoda City Saitama, Japan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614709
- FEI number
- 3009384766
- Address
- 4-15-1 Nagano, Gyoda City Saitama, Japan, 361-0023
- Owner or operator
- DR. JAPAN CO., LTD. (9036222)
- Roles
- Manufacturer
- First device listed
- January 11, 2008
- Registered through
- 2026
- Brand names listed
- Phoenix, RELI, Reli
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 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 |
|---|---|---|---|---|---|---|
| June 2, 2000 | K990519 | PHOENIX EPIDURAL & SPINAL NEEDLES | BSP | Substantially Equivalent | Myco Medical Supplies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
- All makers of Needle, Aspiration And Injection, Disposable
Updated June 2, 2000. 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.