TM-CAPD
FDA 510(k) clearance K812615 · decided 1982-01-05
Clearance details
- K-number
- K812615
- Device name
- TM-CAPD
- Applicant
- Tri-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-15
- Decision date
- 1982-01-05
- Days to decision
- 112 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 |
|---|---|---|
| KPP PERITONEAL DIALYSATE FILTER (K803275) | Millipore Corp. | 1981-03-13 |
| QUIK-TEMP (K800666) | Liquid Crystal Products, Inc. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.