KPP PERITONEAL DIALYSATE FILTER
FDA 510(k) clearance K803275 · decided 1981-03-13
Clearance details
- K-number
- K803275
- Device name
- KPP PERITONEAL DIALYSATE FILTER
- Applicant
- Millipore Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-29
- Decision date
- 1981-03-13
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- KPP
- Device class
- 2
- Regulation number
- 876.5630
- 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 |
|---|---|---|
| TM-CAPD (K812615) | Tri-Med, Inc. | 1982-01-05 |
| QUIK-TEMP (K800666) | Liquid Crystal Products, Inc. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THERAPEUTIC APHERESIS SYSTEM (P850092) | Millipore Corp. | 1986-11-18 |