TUBING, DIALYSATE (AND CONNECTOR)

Tubing, Dialysate

MOLDED PRODUCTS INC.

The following data is part of a premarket notification filed by Molded Products Inc. with the FDA for Tubing, Dialysate (and Connector).

Pre-market Notification Details

Device IDK022068
510k NumberK022068
Device Name:TUBING, DIALYSATE (AND CONNECTOR)
ClassificationTubing, Dialysate
Applicant MOLDED PRODUCTS INC. 601 DURANT ST. Harlan,  IA  51537
ContactElise Johnston
CorrespondentElise Johnston
MOLDED PRODUCTS INC. 601 DURANT ST. Harlan,  IA  51537
Product CodeFID  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-25
Decision Date2002-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B144MPC764AW2 K022068 000
B144MPC1010W2 K022068 000
B144MPC1010R2 K022068 000
B144MPC1010B2 K022068 000
B144MPC7931 K022068 000
B144MPC791W2 K022068 000
B144MPC791R2 K022068 000
B144MPC791B2 K022068 000
B144MPC785PVDF1 K022068 000
B144MPC77XW2 K022068 000
B144MPC7751 K022068 000
B144MPC774WEDPM2 K022068 000
B144MPC1014W2 K022068 000
B144MPC1014R2 K022068 000
B144MPC1011W2 K022068 000
B144MPC6701 K022068 000
B144MPC764AR2 K022068 000
B144MPC764AB2 K022068 000
B144MPC763AW2 K022068 000
B144MPC763AR2 K022068 000
B144MPC763AB2 K022068 000
B144MPC762AW2 K022068 000
B144MPC762AR2 K022068 000
B144MPC762AB2 K022068 000
B144MPC761AW2 K022068 000
B144MPC761AR2 K022068 000
B144MPC761AB2 K022068 000
B144MPC725D1 K022068 000
B144MPC6711 K022068 000
B144MPC1014B2 K022068 000

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