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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K915423
Device Name HEMO-CATH SILICONE ACCESS CATHETER
Applicant
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact ANN EMELE
Correspondent
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact ANN EMELE
Regulation Number876.5540
Classification Product Code
LFJ  
Subsequent Product Code
LFK  
Date Received12/02/1991
Decision Date 02/02/1993
Decision Substantially Equivalent - Kit (SESK)
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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