KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522

Endoscopic Central Control Unit

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 Karl Storz Scb/conmed Esu Interface Module, Model 20091522.

Pre-market Notification Details

Device IDK080410
510k NumberK080410
Device Name:KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
ClassificationEndoscopic Central Control Unit
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactSusie Chen
CorrespondentSusie Chen
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeODA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-14
Decision Date2008-04-09
Summary:summary

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