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FDA 510(k) Application Details - K112628
Device Classification Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
More FDA Info for this Device
510(K) Number
K112628
Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant
NIPRO MEDICAL CORPORATION
3150 N.W. 107TH AVE.
MIAMI, FL 33172 US
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Contact
JESSICA OSWALD
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Regulation Number
876.5820
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Classification Product Code
FJK
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More FDA Info for this Product Code
Date Received
09/09/2011
Decision Date
09/28/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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