EMC MODEL STATOME 200

Electrosurgical, Cutting & Coagulation & Accessories

EMC INDUSTRIES

The following data is part of a premarket notification filed by Emc Industries with the FDA for Emc Model Statome 200.

Pre-market Notification Details

Device IDK952231
510k NumberK952231
Device Name:EMC MODEL STATOME 200
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant EMC INDUSTRIES 1689 MIDDLETON AVE. Los Altos,  CA  94024
ContactPhilip R Hardaker
CorrespondentPhilip R Hardaker
EMC INDUSTRIES 1689 MIDDLETON AVE. Los Altos,  CA  94024
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-12
Decision Date1995-11-21

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