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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal Dialysis, Single Use
510(k) Number K860155
Device Name PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
Applicant
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact MICHEAL I BASTA
Correspondent
Medical Components, Inc.
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact MICHEAL I BASTA
Regulation Number876.5630
Classification Product Code
FKO  
Date Received01/16/1986
Decision Date 02/14/1986
Decision Substantially Equivalent - With Drug (SESD)
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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