UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5

Set, Administration, For Peritoneal Dialysis, Disposable

NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.

The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Universal Connector Catalog No. 48-1025-5.

Pre-market Notification Details

Device IDK896764
510k NumberK896764
Device Name:UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
ClassificationSet, Administration, For Peritoneal Dialysis, Disposable
Applicant NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh,  NJ  07647
ContactJohn R Trembley
CorrespondentJohn R Trembley
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh,  NJ  07647
Product CodeKDJ  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-01
Decision Date1990-02-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.