Cleared Traditional

Mini Sterilizable Tray

K200858 · Implant Direct Sybron Manufacturing, LLC · General Hospital

Aug 2020

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K200858 is an FDA 510(k) clearance for the Mini Sterilizable Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on August 6, 2020, 127 days after receiving the submission on April 1, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K200858 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2020
Decision Date	August 06, 2020
Days to Decision	127 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850