FB-U Hemodialyzer
FDA 510(k) clearance K160444 · decided 2017-02-08
Clearance details
- K-number
- K160444
- Device name
- FB-U Hemodialyzer
- Applicant
- Nipro Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-02-17
- Decision date
- 2017-02-08
- Days to decision
- 357 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.