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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K002816
Device Name TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
Applicant
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Applicant Contact MARK S ALSBERGE
Correspondent
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Correspondent Contact MARK S ALSBERGE
Regulation Number876.5820
Classification Product Code
KOC  
Date Received09/11/2000
Decision Date 11/22/2000
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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