STORZ MODULITH, MODEL SLX-F2

Lithotriptor, Extracorporeal Shock-wave, Urological

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Storz Modulith, Model Slx-f2.

Pre-market Notification Details

Device IDK040476
510k NumberK040476
Device Name:STORZ MODULITH, MODEL SLX-F2
ClassificationLithotriptor, Extracorporeal Shock-wave, Urological
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactRenate A Maclaren
CorrespondentRenate A Maclaren
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeLNS  
CFR Regulation Number876.5990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-24
Decision Date2004-08-26
Summary:summary

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