3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization— 510(k) K150477

Name: FDA 510(k) clearance K150477
Creator: U.S. Food and Drug Administration
Published: 2015-07-02

Substantially Equivalent

3M Company

FDA 510(k) clearance K150477 for 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization, Substantially Equivalent on 2015-07-02. Applicant: 3M Company. Device class: 2.

Clearance details

Applicant: 3M Company
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2015-02-24
Decision date: 2015-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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