ACUTE PERITONEAL DIALYSIS KIT

Catheter, Peritoneal Dialysis, Single Use

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Acute Peritoneal Dialysis Kit.

Pre-market Notification Details

Device IDK870472
510k NumberK870472
Device Name:ACUTE PERITONEAL DIALYSIS KIT
ClassificationCatheter, Peritoneal Dialysis, Single Use
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactJanet L Morris
CorrespondentJanet L Morris
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeFKO  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-03
Decision Date1987-02-25

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