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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K233578
Device Name BAHADIR STERILIZATION CONTAINERS
Applicant
Bahadir USA, LLC
431 S. Pennsville Auburn Rd.
Carneys Point,  NJ  08069
Applicant Contact Ismail Kilic
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number880.6850
Classification Product Code
KCT  
Date Received11/07/2023
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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