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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K900106
Device Name CLOSED DISCONNECT SYSTEM
Applicant
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Applicant Contact RONALD GUIDO
Correspondent
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Correspondent Contact RONALD GUIDO
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received01/09/1990
Decision Date 07/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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