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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 K863218
Device Name CYTOSTATIC FILTRATION SET
Applicant
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact JANE AOYAGI
Correspondent
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact JANE AOYAGI
Regulation Number876.5540
Classification Product Code
LFK  
Date Received08/20/1986
Decision Date 02/12/1987
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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