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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Femoral
510(k) Number K862771
Device Name MEDCOMP C.A.V.H. CATHETER
Applicant
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact RACHEL D RICHARDSON
Correspondent
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact RACHEL D RICHARDSON
Regulation Number876.5540
Classification Product Code
LFK  
Date Received07/22/1986
Decision Date 08/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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