MODIFICATION TO SECURACATH, MODEL: SPK01— 510(k) K083081

Name: FDA 510(k) clearance K083081
Creator: U.S. Food and Drug Administration
Published: 2009-03-04

Substantially Equivalent

Interrad Medical, Inc.

FDA 510(k) clearance K083081 for MODIFICATION TO SECURACATH, MODEL: SPK01, Substantially Equivalent on 2009-03-04. Applicant: Interrad Medical, Inc.. Device class: 2.

Clearance details

Applicant: Interrad Medical, Inc.
Product code: Code OKC
Device class: Class 2
Regulation: 21 CFR 880.5970
Advisory panel: General Hospital
Date received: 2008-10-16
Decision date: 2009-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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