PLEUROFIX THORACENTESIS KIT— 510(k) K820004

Name: FDA 510(k) clearance K820004
Creator: U.S. Food and Drug Administration
Published: 1982-02-04

Substantially Equivalent

Burron Medical Products, Inc.

FDA 510(k) clearance K820004 for PLEUROFIX THORACENTESIS KIT, Substantially Equivalent on 1982-02-04. Applicant: Burron Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Burron Medical Products, Inc.
Product code: Code GAZ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1982-01-04
Decision date: 1982-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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