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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,long-term greater than 30 days
510(k) Number K122423
Device Name VASU-PICC
Original Applicant
1499 delp drive
harleysville,  PA  19438
Original Contact jessica leo
Regulation Number880.5970
Classification Product Code
Date Received08/09/2012
Decision Date 12/12/2012
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