KSEA NEURO-FIBERSCOPE

Endoscope, Neurological

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 Ksea Neuro-fiberscope.

Pre-market Notification Details

Device IDK991069
510k NumberK991069
Device Name:KSEA NEURO-FIBERSCOPE
ClassificationEndoscope, Neurological
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin Kennan
CorrespondentKevin Kennan
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-31
Decision Date1999-06-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.