BAHADIR STERILIZATION TRAYS— 510(k) K102146

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

2010-07-30

Decision date

2010-11-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lindenhurst, NY, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102146.