PROOF (BIOLOGICAL/CHEMICAL INDICATOR)— 510(k) K801109

Name: FDA 510(k) clearance K801109
Creator: U.S. Food and Drug Administration
Published: 1980-05-30

Substantially Equivalent

Amsco Co.

FDA 510(k) clearance K801109 for PROOF (BIOLOGICAL/CHEMICAL INDICATOR), Substantially Equivalent on 1980-05-30. Applicant: Amsco Co.. Device class: 2.

Clearance details

Applicant: Amsco Co.
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1980-05-12
Decision date: 1980-05-30
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.