ELECTROCAUTERY PROBE

Electrosurgical, Cutting & Coagulation & Accessories

WILTEK MEDICAL, INC.

The following data is part of a premarket notification filed by Wiltek Medical, Inc. with the FDA for Electrocautery Probe.

Pre-market Notification Details

Device IDK910334
510k NumberK910334
Device Name:ELECTROCAUTERY PROBE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem,  NC  27116
ContactJon S Wilson
CorrespondentJon S Wilson
WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem,  NC  27116
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-25
Decision Date1991-02-21

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