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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 K000592
Device Name UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
Applicant
MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY,  NC  27513
Applicant Contact SANJIV KUMAR
Correspondent
MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY,  NC  27513
Correspondent Contact SANJIV KUMAR
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/22/2000
Decision Date 04/12/2001
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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