510(k) K253047
- Device
- PRESSONE
- Applicant
- Nipro Medical Corporation
- 510(k) number
- K253047
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-24
- Date received
- 2025-09-22
- 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
- Jessica Oswald-McLeod
- Address
- 3150 NW 107th Ave. Miami FL US 33172 33172
FDA Registration Numbers
- 3014654360
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Source Documents
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