NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,

Electrosurgical, Cutting & Coagulation & Accessories

RICHARDS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Non/gel Fully Adhesive Dispersive Electrode 3428,.

Pre-market Notification Details

Device IDK851305
510k NumberK851305
Device Name:NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428,
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactJim Lenick
CorrespondentJim Lenick
RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-01
Decision Date1985-09-06

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