Cleared Traditional

Wire Sterilization Package with Indicators

K143117 · American Orthodontics · General Hospital
Oct 2015
Decision
364d
Days
Class 2
Risk

About This 510(k) Submission

K143117 is an FDA 510(k) clearance for the Wire Sterilization Package with Indicators, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on October 29, 2015, 364 days after receiving the submission on October 30, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K143117 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2014
Decision Date October 29, 2015
Days to Decision 364 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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