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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K870412
Device Name TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT
Applicant
Medical Surgical Concepts, Inc.
725 W. Second St.
Lansdale,  PA  19446
Applicant Contact ALAN P SCHWARTZ
Correspondent
Medical Surgical Concepts, Inc.
725 W. Second St.
Lansdale,  PA  19446
Correspondent Contact ALAN P SCHWARTZ
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/03/1987
Decision Date 05/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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