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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K010279
Device Name MEDISYSTEMS LUER ACCESS INJECTION SITE
Applicant
Medisystems Corp.
701 Pike St., Suite 1600
Seattle,  WA  98101
Applicant Contact KAREN KRSTULICH
Correspondent
Medisystems Corp.
701 Pike St., Suite 1600
Seattle,  WA  98101
Correspondent Contact KAREN KRSTULICH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/30/2001
Decision Date 05/29/2001
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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