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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 K900142
Device Name DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
Applicant
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Applicant Contact JOHN R TREMBLEY
Correspondent
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Correspondent Contact JOHN R TREMBLEY
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received01/11/1990
Decision Date 03/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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