TEFLON COATED ELECTRODES/ELECTRODES HANDLES

Electrosurgical, Cutting & Coagulation & Accessories

OLSEN ELECTROSURGICAL, INC.

The following data is part of a premarket notification filed by Olsen Electrosurgical, Inc. with the FDA for Teflon Coated Electrodes/electrodes Handles.

Pre-market Notification Details

Device IDK913108
510k NumberK913108
Device Name:TEFLON COATED ELECTRODES/ELECTRODES HANDLES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord,  CA  94520
ContactEugene W Olsen
CorrespondentEugene W Olsen
OLSEN ELECTROSURGICAL, INC. 2100 MERIDIAN PARK BLVD. Concord,  CA  94520
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-12
Decision Date1991-12-23

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