SILICONE SOFT-PAK EPISTAXIS CATHETER— 510(k) K832476

Name: FDA 510(k) clearance K832476
Creator: U.S. Food and Drug Administration
Published: 1983-11-03

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K832476 for SILICONE SOFT-PAK EPISTAXIS CATHETER, Substantially Equivalent on 1983-11-03. Applicant: Axiom Medical, Inc.. Device class: 1.

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code ENW
Device class: Class 1
Regulation: 21 CFR 874.4175
Advisory panel: Ear, Nose, Throat
Date received: 1983-07-26
Decision date: 1983-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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