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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 STREET, SUITE 1600
SEATTLE,  WA  98101 -3016
Applicant Contact KAREN KRSTULICH
Correspondent
MEDISYSTEMS CORP.
701 PIKE STREET, SUITE 1600
SEATTLE,  WA  98101 -3016
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
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