STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION

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 Slk Lithotripter With Multiview Option.

Pre-market Notification Details

Device IDK012482
510k NumberK012482
Device Name:STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
ClassificationLithotriptor, Extracorporeal Shock-wave, Urological
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJennifer Portugal
CorrespondentJennifer Portugal
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 Received2001-08-02
Decision Date2001-10-16
Summary:summary

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