LTFS230

Lithotriptor, Extracorporeal Shock-wave, Urological

HEALTHTRONICS, INC.

The following data is part of a premarket notification filed by Healthtronics, Inc. with the FDA for Ltfs230.

Pre-market Notification Details

Device IDK021775
510k NumberK021775
Device Name:LTFS230
ClassificationLithotriptor, Extracorporeal Shock-wave, Urological
Applicant HEALTHTRONICS, INC. 1841 WEST OAK PKWY. Marietta,  GA  30062
ContactPeter Weiman
CorrespondentPeter Weiman
HEALTHTRONICS, INC. 1841 WEST OAK PKWY. Marietta,  GA  30062
Product CodeLNS  
CFR Regulation Number876.5990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-29
Decision Date2002-12-23
Summary:summary

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