CATHETER ADAPTER SEALING CAP NO. 48-1028-9

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 Catheter Adapter Sealing Cap No. 48-1028-9.

Pre-market Notification Details

Device IDK900006
510k NumberK900006
Device Name:CATHETER ADAPTER SEALING CAP NO. 48-1028-9
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 Received1990-01-02
Decision Date1990-02-27

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