ARTHREX AR-8200 SHAVER SYSTEM

Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ar-8200 Shaver System.

Pre-market Notification Details

Device IDK932699
510k NumberK932699
Device Name:ARTHREX AR-8200 SHAVER SYSTEM
ClassificationInstrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Applicant ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples,  FL  33942
ContactBaltz, Jr
CorrespondentBaltz, Jr
ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples,  FL  33942
Product CodeHWE  
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-03
Decision Date1994-01-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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