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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter,intravascular,therapeutic,short-term less than 30 days
510(k) Number K121488
Device Name JMS SAFE WING CATH (SWC)
Original Applicant
JMS NORTH AMERICA CORPORATION
1468 harwell ave.
crofton,  MD  21114
Original Contact yolanda smith
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/18/2012
Decision Date 03/05/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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