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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reservoir, blood, cardiopulmonary bypass
510(k) Number K012942
Device Name THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
Applicant
CIRCULATORY TECHNOLOGY, INC.
21 SINGWORTH ST.
OYSTER BAY,  NY  11771
Applicant Contact YEHUDA TAMARI
Correspondent
CIRCULATORY TECHNOLOGY, INC.
21 SINGWORTH ST.
OYSTER BAY,  NY  11771
Correspondent Contact YEHUDA TAMARI
Regulation Number870.4400
Classification Product Code
DTN  
Date Received08/31/2001
Decision Date 11/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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