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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 K920671
Device Name DIGI -FLOW
Applicant
D and D Technology, Inc.
693 Seneca St.
Buffalo,  NY  14210
Applicant Contact DENNIS A KWACZALA
Correspondent
D and D Technology, Inc.
693 Seneca St.
Buffalo,  NY  14210
Correspondent Contact DENNIS A KWACZALA
Regulation Number876.5820
Classification Product Code
KOC  
Date Received02/13/1992
Decision Date 01/28/1993
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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