DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K— 510(k) K971411

Name: FDA 510(k) clearance K971411
Creator: U.S. Food and Drug Administration
Published: 1997-06-03

Substantially Equivalent

Bentec Medical, Inc.

FDA 510(k) clearance K971411 for DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K, Substantially Equivalent on 1997-06-03. Applicant: Bentec Medical, Inc.. Device class: 1.

Clearance details

Applicant: Bentec Medical, Inc.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1997-04-16
Decision date: 1997-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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