MILES SODIUM METHOD

Electrode, Electrosurgical

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Miles Sodium Method.

Pre-market Notification Details

Device IDK923037
510k NumberK923037
Device Name:MILES SODIUM METHOD
ClassificationElectrode, Electrosurgical
Applicant HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactRobert L Habig
CorrespondentRobert L Habig
HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeJOS  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-19
Decision Date1992-09-22

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