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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 K051783
Device Name ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
Applicant
Artsana S.P.A
22411 60th St.
Bristol,  WI  53104
Applicant Contact LARA N SIMMONS
Correspondent
Artsana S.P.A
22411 60th St.
Bristol,  WI  53104
Correspondent Contact LARA N SIMMONS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/01/2005
Decision Date 10/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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