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510(k) K072024

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 by Nipro Medical Corp. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2007
Date Received
July 24, 2007
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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  • K052474 — NIPRO HYPODERMIC NEEDLE (November 10, 2005)
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  • K032777 — MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE (November 14, 2003)
  • K030683 — NIPRO DISPOSABLE SYRINGES (October 31, 2003)
  • K022756 — NIPRO BIO-FLEX CATHETER (October 18, 2002)

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