MAGNATEK C-300

Electrosurgical, Cutting & Coagulation & Accessories

MAGNA ADVANCED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Magna Advanced Technologies, Inc. with the FDA for Magnatek C-300.

Pre-market Notification Details

Device IDK981310
510k NumberK981310
Device Name:MAGNATEK C-300
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami,  FL  33126
ContactAnnie Velez
CorrespondentAnnie Velez
MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami,  FL  33126
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-10
Decision Date1998-07-09

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