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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 K131407
Device Name BAHADIR STERILIZATION TRAYS
Applicant
Bahadir USA Corp.
275 W. Hoffman Ave.
Lindenhurst,  NY  11757
Applicant Contact ISMAIL KILIC
Correspondent
Bahadir USA Corp.
275 W. Hoffman Ave.
Lindenhurst,  NY  11757
Correspondent Contact ISMAIL KILIC
Regulation Number880.6850
Classification Product Code
KCT  
Date Received05/15/2013
Decision Date 08/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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