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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 K040992
Device Name 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
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 Number876.5540
Classification Product Code
MSD  
Date Received04/16/2004
Decision Date 07/29/2004
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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