KEITH-A.R.V.
FDA 510(k) clearance K851444 · decided 1985-05-10
Clearance details
- K-number
- K851444
- Device name
- KEITH-A.R.V.
- Applicant
- Karl M. Block Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-11
- Decision date
- 1985-05-10
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE M recall (Z-0209-2026) | Cardinal Health 200, LLC | 2025-10-17 |