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510(k) K233578

Device
BAHADIR STERILIZATION CONTAINERS
Applicant
Bahadir USA, LLC
510(k) number
K233578
Product code
KCT
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-22
Date received
2023-11-07
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
Ismail Kilic
Address
431 S. Pennsville Auburn Rd. Carneys Point NJ US 08069 08069

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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