MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD

Electrosurgical, Cutting & Coagulation & Accessories

ELECTROSCOPE, INC.

The following data is part of a premarket notification filed by Electroscope, Inc. with the FDA for Monopolar Laparoscopic Electrodes W/eletroshield.

Pre-market Notification Details

Device IDK912780
510k NumberK912780
Device Name:MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ELECTROSCOPE, INC. 4890 STERLING DR. Boulder,  CO  80301
ContactRoger C.odell
CorrespondentRoger C.odell
ELECTROSCOPE, INC. 4890 STERLING DR. Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-24
Decision Date1991-12-30

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