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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, hemodialysis, non-implanted
510(k) Number K071145
Device Name NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
Applicant
NIPRO MEDICAL CORPORATION
3150 N.W. 107TH AVE.
MIAMI,  FL  33172
Applicant Contact JESSICA OSWALD
Correspondent
NIPRO MEDICAL CORPORATION
3150 N.W. 107TH AVE.
MIAMI,  FL  33172
Correspondent Contact JESSICA OSWALD
Regulation Number876.5540
Classification Product Code
MPB  
Subsequent Product Codes
KOC   LLB  
Date Received04/24/2007
Decision Date 09/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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