ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE

Arthroscope

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Dual Wave Arthroscopy Fluid Management Device.

Pre-market Notification Details

Device IDK083707
510k NumberK083707
Device Name:ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
ClassificationArthroscope
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactSally Foust
CorrespondentSally Foust
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-15
Decision Date2009-08-03
Summary:summary

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