WOUND FLUSH, STERILE WATER & NORMAL SALINE

Dressing, Wound, Drug

NURSE ASSIST, INC.

The following data is part of a premarket notification filed by Nurse Assist, Inc. with the FDA for Wound Flush, Sterile Water & Normal Saline.

Pre-market Notification Details

Device IDK083042
510k NumberK083042
Device Name:WOUND FLUSH, STERILE WATER & NORMAL SALINE
ClassificationDressing, Wound, Drug
Applicant NURSE ASSIST, INC. 1415 HALSEY WAY, SUITE 304 Carrollton,  TX  75007 -4455
ContactDenice Gallagher
CorrespondentDenice Gallagher
NURSE ASSIST, INC. 1415 HALSEY WAY, SUITE 304 Carrollton,  TX  75007 -4455
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-10-14
Decision Date2008-12-18
Summary:summary

NIH GUDID Devices

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