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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K964337
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 Number876.5820
Classification Product Code
FIB  
Subsequent Product Code
DTN  
Date Received10/31/1996
Decision Date 05/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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