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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
Original Applicant
north industrial zone
kiryat shmona,  IL 10258
Original Contact yossi shachar
Regulation Number880.5440
Classification Product Code
Date Received04/26/2012
Decision Date 01/22/2013
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