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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K113429
Device Name SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
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 Number880.5200
Classification Product Code
FOZ  
Date Received11/21/2011
Decision Date 03/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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