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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K090502
Device Name NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
Applicant
U.S. SAFETY SYRINGES CO., INC.
1676 VILLAGE GREEN
CROFTON,  MD  21114
Applicant Contact CHRISTINA SMITH
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/25/2009
Decision Date 03/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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