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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, repair, catheter, hemodialysis
510(k) Number K022570
Device Name MEDCOMP REPAIR KIT, MODEL ASPCRPK
Applicant
MEDCOMP
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact FLORENCE A CAIKOSKI
Correspondent
MEDCOMP
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact FLORENCE A CAIKOSKI
Regulation Number876.5540
Classification Product Code
NFK  
Date Received08/02/2002
Decision Date 10/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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