ULTRASONIC TRANSMISSION GEL

Electrode, Gel, Electrosurgical

HERBERT STANLEY CO.

The following data is part of a premarket notification filed by Herbert Stanley Co. with the FDA for Ultrasonic Transmission Gel.

Pre-market Notification Details

Device IDK884503
510k NumberK884503
Device Name:ULTRASONIC TRANSMISSION GEL
ClassificationElectrode, Gel, Electrosurgical
Applicant HERBERT STANLEY CO. 8140 N. RIDGEWAY Skokie,  IL  60076
ContactB Demasi
CorrespondentB Demasi
HERBERT STANLEY CO. 8140 N. RIDGEWAY Skokie,  IL  60076
Product CodeJOT  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-25
Decision Date1989-02-13

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