RENALSOFT— 510(k) K061515
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K061515 for RENALSOFT, Substantially Equivalent on 2006-09-11. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code KPF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
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