UNIVERSAL IRRIGATION SOLUTION HYBRID

Endoscopic Irrigation/suction System

BYRNE MEDICAL, INC.

The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Universal Irrigation Solution Hybrid.

Pre-market Notification Details

Device IDK102855
510k NumberK102855
Device Name:UNIVERSAL IRRIGATION SOLUTION HYBRID
ClassificationEndoscopic Irrigation/suction System
Applicant BYRNE MEDICAL, INC. 3150 POLLOCK DR. Conroe,  TX  77303
ContactJohn Willis
CorrespondentJohn Willis
BYRNE MEDICAL, INC. 3150 POLLOCK DR. Conroe,  TX  77303
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-29
Decision Date2010-11-19
Summary:summary

NIH GUDID Devices

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