CONTEX— 510(k) K790995

Substantially Equivalent

Foam Tek, Inc.

FDA 510(k) clearance K790995 for CONTEX, Substantially Equivalent on 1979-06-11. Applicant: Foam Tek, Inc.. Device class: 1.

Clearance details

Applicant: Foam Tek, Inc.
Product code: Code FMP
Device class: Class 1
Regulation: 21 CFR 880.6450
Advisory panel: General Hospital
Date received: 1979-05-29
Decision date: 1979-06-11
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.