PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT— 510(k) K854084

Name: FDA 510(k) clearance K854084
Creator: U.S. Food and Drug Administration
Published: 1985-11-08

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K854084 for PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT, Substantially Equivalent on 1985-11-08. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FKL
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-10-07
Decision date: 1985-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

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