PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210— 510(k) K001685
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K001685 for PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210, Substantially Equivalent on 2000-11-15. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code MSE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.