STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000

Generator, Lesion, Radiofrequency

SYNERGETICS, INC

The following data is part of a premarket notification filed by Synergetics, Inc with the FDA for Stryker Rf Multi-lesion Generator, Model 0406-900-000.

Pre-market Notification Details

Device IDK071482
510k NumberK071482
Device Name:STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
ClassificationGenerator, Lesion, Radiofrequency
Applicant SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon,  MO  63368
ContactDan Regan
CorrespondentDan Regan
SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon,  MO  63368
Product CodeGXD  
CFR Regulation Number882.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-30
Decision Date2007-12-20
Summary:summary

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