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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 K160199
Device Name Advocate Insulin Pen Needles
Diabetic Supply of Suncoast, Inc.
Bo.Espinosa Carr.2km.26.2
Dorado,  PR  00646 -9532
Applicant Contact Victoria Thuss
Matt Hedlund
3924 NE 157th PL
Lake Forest Park,  WA  98155
Correspondent Contact Matt Hedlund
Regulation Number880.5570
Classification Product Code
Date Received01/28/2016
Decision Date 10/19/2016
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