INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE

Electrode, Electrosurgical

DERMACARE PRODUCTS, INC.

The following data is part of a premarket notification filed by Dermacare Products, Inc. with the FDA for Infant Electrosurgical Dispersive Electrode.

Pre-market Notification Details

Device IDK882421
510k NumberK882421
Device Name:INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE
ClassificationElectrode, Electrosurgical
Applicant DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville,  KT  40214
ContactKen Potts
CorrespondentKen Potts
DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville,  KT  40214
Product CodeJOS  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-13
Decision Date1988-06-30

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