SYNAPS (TM)

Stimulator, Nerve, Transcutaneous, For Pain Relief

HENLEY INTL.

The following data is part of a premarket notification filed by Henley Intl. with the FDA for Synaps (tm).

Pre-market Notification Details

Device IDK903828
510k NumberK903828
Device Name:SYNAPS (TM)
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land,  TX  77470
ContactErnest J Henley
CorrespondentErnest J Henley
HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land,  TX  77470
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-21
Decision Date1991-01-18

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