REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)— 510(k) K954623
Substantially EquivalentGambro Healthcare
FDA 510(k) clearance K954623 for REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR), Substantially Equivalent on 1996-08-28. Applicant: Gambro Healthcare. Device class: 2.
Clearance details
- Applicant
- Gambro Healthcare
- Product code
- Code FKT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5600
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oklahoma City, OK, US
Recent devices under product code FKT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.