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510(k) K121488

JMS SAFE WING CATH (SWC) by JMS North America Corporation — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2013
Date Received
May 18, 2012
Clearance Type
Traditional
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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