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510(k) K140136

NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE by Nipro Medical Corporation — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2014
Date Received
January 17, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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