DISSCAP 110 DIALYZER
FDA 510(k) clearance K851380 · decided 1985-04-25
Clearance details
- K-number
- K851380
- Device name
- DISSCAP 110 DIALYZER
- Applicant
- Hospal Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-08
- Decision date
- 1985-04-25
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- FJI
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- East Brunswick, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.