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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 K893712
Device Name PERITONEAL DIALYSIS SYSTEM AND ACCESS.
Applicant
Delmed, Inc.
120 Albany St.
P.O. Box 2623
New Brunswick,  NJ  08903
Applicant Contact SUSAN REVELJ
Correspondent
Delmed, Inc.
120 Albany St.
P.O. Box 2623
New Brunswick,  NJ  08903
Correspondent Contact SUSAN REVELJ
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received05/18/1989
Decision Date 07/24/1989
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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