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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 K893439
Device Name HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
Applicant
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact NANCY L WILLIAMS
Correspondent
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact NANCY L WILLIAMS
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received05/03/1989
Decision Date 06/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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