TENCKHOFF PERITONEAL DIALYSIS KIT

Dialyzer, Parallel Flow

AKCESS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Tenckhoff Peritoneal Dialysis Kit.

Pre-market Notification Details

Device IDK902203
510k NumberK902203
Device Name:TENCKHOFF PERITONEAL DIALYSIS KIT
ClassificationDialyzer, Parallel Flow
Applicant AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick,  NJ  08901
ContactBalbir Kapany
CorrespondentBalbir Kapany
AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick,  NJ  08901
Product CodeFJG  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-16
Decision Date1990-08-01

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