ISOLATION MASK I.C.S.— 510(k) K831062

Name: FDA 510(k) clearance K831062
Creator: U.S. Food and Drug Administration
Published: 1983-04-13

Substantially Equivalent

American Threshold Industries, Inc.

FDA 510(k) clearance K831062 for ISOLATION MASK I.C.S., Substantially Equivalent on 1983-04-13. Applicant: American Threshold Industries, Inc.. Device class: 2.

Clearance details

Applicant: American Threshold Industries, Inc.
Product code: Code LGM
Device class: Class 2
Regulation: 21 CFR 880.5450
Advisory panel: General Hospital
Date received: 1983-04-08
Decision date: 1983-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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