KARL STORZ TRANS-NASAL ESOPHAGOSCOPE

Esophagoscope (flexible Or Rigid)

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 Trans-nasal Esophagoscope.

Pre-market Notification Details

Device IDK051972
510k NumberK051972
Device Name:KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
ClassificationEsophagoscope (flexible Or Rigid)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactYvonne Fernandez
CorrespondentYvonne Fernandez
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeEOX  
CFR Regulation Number874.4710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-21
Decision Date2005-08-15
Summary:summary

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