HF JUNIOR HEMOFILTER
FDA 510(k) clearance K071298 · decided 2007-08-08
Clearance details
- K-number
- K071298
- Device name
- HF JUNIOR HEMOFILTER
- Applicant
- Minntech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-09
- Decision date
- 2007-08-08
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.