BRESAGEN CATHETER, MODEL CS-3000— 510(k) K021481

Name: FDA 510(k) clearance K021481
Creator: U.S. Food and Drug Administration
Published: 2002-08-06

Substantially Equivalent

Bresagen, Inc.

FDA 510(k) clearance K021481 for BRESAGEN CATHETER, MODEL CS-3000, Substantially Equivalent on 2002-08-06. Applicant: Bresagen, Inc.. Device class: 2.

Clearance details

Applicant: Bresagen, Inc.
Product code: Code HCA
Device class: Class 2
Regulation: 21 CFR 882.4100
Advisory panel: Neurology
Date received: 2002-05-08
Decision date: 2002-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, GA, US

Download summary PDF View on FDA.gov ↗

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