DANA REUSABLE TEST PACK FOR STEAM STERILIZATION— 510(k) K092944

Name: FDA 510(k) clearance K092944
Creator: U.S. Food and Drug Administration
Published: 2010-03-18

Substantially Equivalent

Dana Products, Inc.

FDA 510(k) clearance K092944 for DANA REUSABLE TEST PACK FOR STEAM STERILIZATION, Substantially Equivalent on 2010-03-18. 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: 2009-09-24
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Barrington, IL, US

Download summary PDF View on FDA.gov ↗

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