Delta III Lithotripter

Lithotriptor, Extracorporeal Shock-wave, Urological

Dornier MedTech America, Inc.

The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Delta Iii Lithotripter.

Pre-market Notification Details

Device IDK201074
510k NumberK201074
Device Name:Delta III Lithotripter
ClassificationLithotriptor, Extracorporeal Shock-wave, Urological
Applicant Dornier MedTech America, Inc. 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
ContactJohn Hoffer
CorrespondentJohn Hoffer
Dornier MedTech America, Inc. 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
Product CodeLNS  
CFR Regulation Number876.5990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-22
Decision Date2020-09-03

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