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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 K053345
Device Name PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
Applicant
MEDCOMP
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact JEAN CALLOW
Correspondent
MEDCOMP
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact JEAN CALLOW
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/02/2005
Decision Date 03/17/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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