TWINTRODE ELC 134 ELECTRODE

Lithotriptor, Extracorporeal Shock-wave, Urological

HEALTH TRONICS SURGICAL SERVICES, INC.

The following data is part of a premarket notification filed by Health Tronics Surgical Services, Inc. with the FDA for Twintrode Elc 134 Electrode.

Pre-market Notification Details

Device IDK012785
510k NumberK012785
Device Name:TWINTRODE ELC 134 ELECTRODE
ClassificationLithotriptor, Extracorporeal Shock-wave, Urological
Applicant HEALTH TRONICS SURGICAL SERVICES, INC. 1841 WEST OAK PARKWAY, SUITE A Marietta,  GA  30062
ContactPeter Weiman
CorrespondentPeter Weiman
HEALTH TRONICS SURGICAL SERVICES, INC. 1841 WEST OAK PARKWAY, SUITE A Marietta,  GA  30062
Product CodeLNS  
CFR Regulation Number876.5990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-20
Decision Date2001-11-16
Summary:summary

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