5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY— 510(k) K761287
Substantially EquivalentTravenol Laboratories, S.A.
FDA 510(k) clearance K761287 for 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY, Substantially Equivalent on 1977-01-03. Applicant: Travenol Laboratories, S.A.. Device class: 2.
Clearance details
- Applicant
- Travenol Laboratories, S.A.
- Product code
- Code FKP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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