HEMOCOR HPH MINI HEMOCONCENTRATOR
FDA 510(k) clearance K980859 · decided 1998-05-12
Clearance details
- K-number
- K980859
- Device name
- HEMOCOR HPH MINI HEMOCONCENTRATOR
- Applicant
- Minntech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-05
- Decision date
- 1998-05-12
- Days to decision
- 68 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.