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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K061483
Device Name VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
Applicant
GREINER BIO-ONE NORTH AMERICA, INC.
P.O. BOX 103
BALDWIN,  MD  21013
Applicant Contact Judi Smith
Correspondent
GREINER BIO-ONE NORTH AMERICA, INC.
P.O. BOX 103
BALDWIN,  MD  21013
Correspondent Contact Judi Smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/30/2006
Decision Date 08/14/2006
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
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