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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 K011786
Device Name VACUETTE SAFETY BLOOD COLLECTION SET
Applicant
GREINER VACUETTE NORTH AMERICA, INC.
P.O. BOX 103
BALDWIN,  MD  21013
Applicant Contact Judi Smith
Correspondent
GREINER VACUETTE NORTH AMERICA, INC.
P.O. BOX 103
BALDWIN,  MD  21013
Correspondent Contact Judi Smith
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/08/2001
Decision Date 07/12/2001
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
Recalls CDRH Recalls
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