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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, fistula
510(k) Number K131950
Device Name ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
Applicant
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC.
7 MEADOW WOOD ROAD
KINGSTON,  NH  03848
Applicant Contact RICHELLE HELMAN
Correspondent
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC.
7 MEADOW WOOD ROAD
KINGSTON,  NH  03848
Correspondent Contact RICHELLE HELMAN
Regulation Number876.5540
Classification Product Code
FIE  
Date Received06/27/2013
Decision Date 01/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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