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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K894470
Device Name STRYKER TRAUMA TRAY
Applicant
Stryker Corp.
5600 Silver Oak Ct.
Rockville,  MD  20855
Applicant Contact SALMAN, PH.D.
Correspondent
Stryker Corp.
5600 Silver Oak Ct.
Rockville,  MD  20855
Correspondent Contact SALMAN, PH.D.
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received07/18/1989
Decision Date 08/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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