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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 K121848
Models ASPC24-3, ASPC28-3, ASPC32-3, ASPC36-3, ASPC40-3, ASPC55-3
Device Name SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
Original Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Original Contact jean callow
Regulation Number876.5540
Classification Product Code
MSD  
Date Received06/26/2012
Decision Date 09/21/2012
Decision substantially equivalent - kit (SK)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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