BAHADIR STERILIZATION TRAYS— 510(k) K112090

Clearance details

Applicant

Bahadir USA Corp.

Product code

Code KCT

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

2011-07-21

Decision date

2012-06-07

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Lindenhurst, NY, US

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• Z-2624-2014 — Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.Class II·Terminated·Integra York PA, Inc·20140730

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112090.