REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION

Catheters, Suction, Tracheobronchial

CONTOUR FABRICATORS OF FLORIDA, INC.

The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Redi Nurse System (rns) Sterile Water For Irrigation.

Pre-market Notification Details

Device IDK952395
510k NumberK952395
Device Name:REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION
ClassificationCatheters, Suction, Tracheobronchial
Applicant CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg,  FL  33716
ContactScott Williams
CorrespondentScott Williams
CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg,  FL  33716
Product CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-22
Decision Date1995-08-15

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