PLASTIC MOUTH BARRIER HSV-I— 510(k) K853266

Name: FDA 510(k) clearance K853266
Creator: U.S. Food and Drug Administration
Published: 1985-10-29

Substantially Equivalent

Westmark Enterprises, Inc.

FDA 510(k) clearance K853266 for PLASTIC MOUTH BARRIER HSV-I, Substantially Equivalent on 1985-10-29. Applicant: Westmark Enterprises, Inc.. Device class: 1.

Clearance details

Applicant: Westmark Enterprises, Inc.
Product code: Code BYP
Device class: Class 1
Regulation: 21 CFR 868.5620
Advisory panel: Anesthesiology
Date received: 1985-08-05
Decision date: 1985-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, 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.