MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model Force 100 Bipolar Electrosurgical Generator.

Pre-market Notification Details

Device IDK864851
510k NumberK864851
Device Name:MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
ContactPeggy Walline
CorrespondentPeggy Walline
VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-10
Decision Date1987-01-08

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