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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 K981284
Device Name BETTER-BLADDER (BB)
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 Received04/08/1998
Decision Date 08/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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