AIR VENT LINE CAT. NO. AVL-36— 510(k) K875080

Name: FDA 510(k) clearance K875080
Creator: U.S. Food and Drug Administration
Published: 1988-02-29

Substantially Equivalent

American Omni Medical, Inc.

FDA 510(k) clearance K875080 for AIR VENT LINE CAT. NO. AVL-36, Substantially Equivalent on 1988-02-29. Applicant: American Omni Medical, Inc.. Device class: 2.

Clearance details

Applicant: American Omni Medical, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1987-12-09
Decision date: 1988-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, 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.