MCA 200 HEMPDIALYZER
FDA 510(k) clearance K926372 · decided 1995-02-13
Clearance details
- K-number
- K926372
- Device name
- MCA 200 HEMPDIALYZER
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Decision
- Substantially Equivalent
- Date received
- 1992-12-22
- Decision date
- 1995-02-13
- Days to decision
- 783 days
- Clearance type
- Traditional
- Product code
- FJI
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami Lakes, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.