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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 K093985
Device Name NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
Applicant
NIPRO MEDICAL CORP.
3150 NW 107TH AVE.
MIAMI,  FL  33172
Applicant Contact JESSICA OSWALD
Correspondent
NIPRO MEDICAL CORP.
3150 NW 107TH AVE.
MIAMI,  FL  33172
Correspondent Contact JESSICA OSWALD
Regulation Number876.5540
Classification Product Code
FIE  
Date Received12/24/2009
Decision Date 01/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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