95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS— 510(k) K974090
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K974090 for 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS, Substantially Equivalent on 1998-08-27. Applicant: Fresenius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America
- 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
- Walnut Creek, CA, US
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- K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
More clearances from Fresenius Medical Care North America
view allData sourced from openFDA. This site is unofficial and independent of the FDA.