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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
Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Applicant Contact jean callow
Correspondent
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Correspondent Contact jean callow
Regulation Number880.5970
Classification Product Code
LJS  
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
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