510(k) K250284
- Device
- TSK SELECT Needle
- Applicant
- Tsk Laboratory, Japan
- 510(k) number
- K250284
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-24
- Date received
- 2025-01-31
- Regulation
- 880.5570
- Classification name
- Needle, Hypodermic, Single Lumen
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Yumi Ueda
- Address
- 1510-1, Soja-Machi, Tochigi-Shi Tochigi-Ken JP 328-0002 328-0002
FDA Registration Numbers
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Source Documents
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