HOLLOW FIBER DIALYZER HOLDER
FDA 510(k) clearance K802075 · decided 1980-09-16
Clearance details
- K-number
- K802075
- Device name
- HOLLOW FIBER DIALYZER HOLDER
- Applicant
- Renal Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-27
- Decision date
- 1980-09-16
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- FKI
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMER. BENTLEY HEMOFILTER HOLDER HFH-1 (K843504) | American Bentley | 1984-10-18 |
| PARALLEL PLATE DIALYZER HOLDER (K811292) | Extracorporeal Medical Specialities, Inc. | 1981-06-02 |
Recalls involving this device
No recalls on record reference this clearance.