BERGEN MODEL 500 ELECTROSURGERY GENERATOR

Electrosurgical, Cutting & Coagulation & Accessories

BERGEN MFG.

The following data is part of a premarket notification filed by Bergen Mfg. with the FDA for Bergen Model 500 Electrosurgery Generator.

Pre-market Notification Details

Device IDK972299
510k NumberK972299
Device Name:BERGEN MODEL 500 ELECTROSURGERY GENERATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BERGEN MFG. 9345 ROOKERY RD. Newport Richey,  FL  34654
ContactRoger Oosten
CorrespondentRoger Oosten
BERGEN MFG. 9345 ROOKERY RD. Newport Richey,  FL  34654
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-19
Decision Date1997-08-27
Summary:summary

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