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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 K093309
Device Name PRO-LINE CT (BASIC TRAY) MODEL MR28036101
Applicant
Medcomp ( Medical Components)
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact JEAN CALLOW
Correspondent
Medcomp ( Medical Components)
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact JEAN CALLOW
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/22/2009
Decision Date 11/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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