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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 K140136
Device Name NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
Applicant
NIPRO MEDICAL CORPORATION
3150 N.W. 107TH AVE.
DORAL,  FL  33172
Applicant Contact JESSICA OSWALD-MCLEOD
Correspondent
NIPRO MEDICAL CORPORATION
3150 N.W. 107TH AVE.
DORAL,  FL  33172
Correspondent Contact JESSICA OSWALD-MCLEOD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/17/2014
Decision Date 02/14/2014
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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