PLASMA FLEX— 510(k) K811523

Substantially Equivalent

Terumo America, Inc.

FDA 510(k) clearance K811523 for PLASMA FLEX, Substantially Equivalent on 1981-09-09. Applicant: Terumo America, Inc.. Device class: 2.

Clearance details

Applicant: Terumo America, Inc.
Product code: Code KSR
Device class: Class 2
Regulation: 21 CFR 864.9100
Advisory panel: Hematology
Date received: 1981-05-29
Decision date: 1981-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER1980-08-12
K801193 — CLIRANS TE15 HOLLOW FIBER DIALYZER1980-08-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.