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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 K151341
Device Name Turbo High-Flow Non-coring Needle
Applicant
Norfolk Medical
7350 N. Ridgeway Ave.
Skokie,  IL  60076
Applicant Contact NATAN PHEIL
Correspondent
Norfolk Medical
7350 N. Ridgeway Ave.
Skokie,  IL  60076
Correspondent Contact NATAN PHEIL
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/19/2015
Decision Date 08/20/2015
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
Predetermined Change
Control Plan Authorized		 No
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