BERGEN 610 BIPOLAR COAGULATOR

Electrosurgical, Cutting & Coagulation & Accessories

BERGEN MFG.

The following data is part of a premarket notification filed by Bergen Mfg. with the FDA for Bergen 610 Bipolar Coagulator.

Pre-market Notification Details

Device IDK964736
510k NumberK964736
Device Name:BERGEN 610 BIPOLAR COAGULATOR
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 Received1996-11-25
Decision Date1997-02-27
Summary:summary

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