VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON

Stimulator, Electrical, Non-implantable, For Incontinence

HOLLISTER, INC.

The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Vaginal 2 Electrode Stimulation/emg Probe - Tampon.

Pre-market Notification Details

Device IDK971541
510k NumberK971541
Device Name:VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
ContactJoseph S Tokarz
CorrespondentJoseph S Tokarz
HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-28
Decision Date1997-06-25
Summary:summary

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