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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, hemodialysis, implanted
510(k) Number K113487
Device Name HEMO-CATH 10F, HEMO-CATH 12.5F
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 Number876.5540
Classification Product Code
MSD  
Date Received11/23/2011
Decision Date 03/09/2012
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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