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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 K120981
Device Name 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
Original Applicant
1499 delp drive
harleysville,  PA  19438
Original Contact jean callow
Regulation Number880.5970
Classification Product Code
Date Received04/02/2012
Decision Date 05/02/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No