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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 K123617
Device Name 3F PRO-PICC
Applicant
MEDICAL COMPONENTS INC
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Applicant Contact JESSICA LEO
Correspondent
MEDICAL COMPONENTS INC
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Correspondent Contact JESSICA LEO
Regulation Number880.5970
Classification Product Code
LJS  
Date Received11/23/2012
Decision Date 05/15/2013
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
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