LASER GAS MIXTURE

Powered Laser Surgical Instrument

NORDAN SMITH WELDING SUPPLIES

The following data is part of a premarket notification filed by Nordan Smith Welding Supplies with the FDA for Laser Gas Mixture.

Pre-market Notification Details

Device IDK942865
510k NumberK942865
Device Name:LASER GAS MIXTURE
ClassificationPowered Laser Surgical Instrument
Applicant NORDAN SMITH WELDING SUPPLIES 5051 HIGHWAY 42 P.O. BOX 107 Hattiesburg,  MS  39403
ContactWilliam Dowden
CorrespondentWilliam Dowden
NORDAN SMITH WELDING SUPPLIES 5051 HIGHWAY 42 P.O. BOX 107 Hattiesburg,  MS  39403
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-17
Decision Date1994-08-23

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