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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K081210
Device Name NIPRO SAFETOUCH HUBER INFUSTION SET
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 Number880.5440
Classification Product Code
FPA  
Date Received04/29/2008
Decision Date 10/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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