FDA.reportPublic FDA data

510(k) K223672

Device
Instrument Case P1340904
Applicant
Cochlear
510(k) number
K223672
Product code
KCT
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-21
Date received
2022-12-07
Regulation
880.6850
Classification name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Denis DiMartino
Address
10350 Park Meadows Dr. Lone Tree CO US 80124 80124

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.2026-02-06
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K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC2025-06-20
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K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies2025-05-01