GAMBRO HEMOFREEZE-BAG— 510(k) K801082

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K801082 for GAMBRO HEMOFREEZE-BAG, Substantially Equivalent on 1980-10-31. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code KSR
Device class: Class 2
Regulation: 21 CFR 864.9100
Advisory panel: Hematology
Date received: 1980-05-07
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.