DISPOSABLE THERMOPLASTIC RUBBER MOUTH— 510(k) K821128

Name: FDA 510(k) clearance K821128
Creator: U.S. Food and Drug Administration
Published: 1982-05-13

Substantially Equivalent

Airlife, Inc.

FDA 510(k) clearance K821128 for DISPOSABLE THERMOPLASTIC RUBBER MOUTH, Substantially Equivalent on 1982-05-13. Applicant: Airlife, Inc.. Device class: 1.

Clearance details

Applicant: Airlife, Inc.
Product code: Code BYP
Device class: Class 1
Regulation: 21 CFR 868.5620
Advisory panel: Anesthesiology
Date received: 1982-04-20
Decision date: 1982-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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