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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K910004
Device Name FURUI SHUNT, 2-WAY AND 3-WAY
Applicant
Theramed, Inc.
P.O. Box 5886
Ft. Lauderdale,  FL  33310
Applicant Contact CHARLES HOKANSON
Correspondent
Theramed, Inc.
P.O. Box 5886
Ft. Lauderdale,  FL  33310
Correspondent Contact CHARLES HOKANSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/02/1991
Decision Date 09/19/1991
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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