DANA REUSABLE TEST PACK— 510(k) K133267

Substantially Equivalent

Dana Products, Inc.

FDA 510(k) clearance K133267 for DANA REUSABLE TEST PACK, Substantially Equivalent on 2014-02-11. Applicant: Dana Products, Inc.. Device class: 2.

Clearance details

Applicant: Dana Products, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2013-10-24
Decision date: 2014-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Barrington, IL, 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.