SORB 10 DIALYSATE INFUSATE C1 INFUSATE— 510(k) K801440

Name: FDA 510(k) clearance K801440
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K801440 for SORB 10 DIALYSATE INFUSATE C1 INFUSATE, Substantially Equivalent on 1980-07-21. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FKT
Device class: Class 2
Regulation: 21 CFR 876.5600
Advisory panel: Gastroenterology, Urology
Date received: 1980-06-20
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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