HEMOPERFUSION SYSTEM TP-400— 510(k) K840532
Substantially EquivalentExtracorporeal Medical Specialities, Inc.
FDA 510(k) clearance K840532 for HEMOPERFUSION SYSTEM TP-400, Substantially Equivalent on 1984-05-30. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.
Clearance details
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Product code
- Code FLD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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