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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 K151311
Device Name Safe Block Pen Needle
Applicant
Artsana S.P.A
Via Saldarini Catelli 1
Grandate,  IT 22070
Applicant Contact Cassani Mauro
Correspondent
Wood Burditt Group
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact H. Carl Jenkins
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/18/2015
Decision Date 02/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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