HEMODIALYSIS TUBING SETS
FDA 510(k) clearance K001971 · decided 2001-05-24
Clearance details
- K-number
- K001971
- Device name
- HEMODIALYSIS TUBING SETS
- Applicant
- Ofi Biomedica S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-28
- Decision date
- 2001-05-24
- Days to decision
- 330 days
- Clearance type
- Traditional
- Product code
- FIB
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.