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510(k) K112628

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET by Nipro Medical Corporation — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2012
Date Received
September 9, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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