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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(K) Number K121269
Device Name TBA
Applicant
MIGADA PLANT
north industrial zone
kiryat shmona, 
Contact yossi shachar
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/26/2012
Decision Date 01/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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