HAEMONETICS 1000ML COMPONENT BAG— 510(k) K811449

Name: FDA 510(k) clearance K811449
Creator: U.S. Food and Drug Administration
Published: 1981-07-01

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K811449 for HAEMONETICS 1000ML COMPONENT BAG, Substantially Equivalent on 1981-07-01. Applicant: Haemonetics Corp.. Device class: 2.

Clearance details

Applicant: Haemonetics Corp.
Product code: Code KSR
Device class: Class 2
Regulation: 21 CFR 864.9100
Advisory panel: Hematology
Date received: 1981-05-22
Decision date: 1981-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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