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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 K102146
Device Name BAHADIR STERILIZATION TRAYS
Applicant
BAHADIR USA CORP.
275 WEST HOFFMAN AVENUE
LINDENHURST,  NY  11757
Applicant Contact ISMAIL KILIC
Correspondent
BAHADIR USA CORP.
275 WEST HOFFMAN AVENUE
LINDENHURST,  NY  11757
Correspondent Contact ISMAIL KILIC
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/30/2010
Decision Date 11/18/2010
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
Recalls CDRH Recalls
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