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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 K121094
Device Name MEDCOMP VASCU-PICC & MIDLINE CATHETERS
Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Contact jean callow
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/10/2012
Decision Date 06/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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