KSEA SCB MEDIA CONTROL

Light, Surgical, Accessories

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 Scb Media Control.

Pre-market Notification Details

Device IDK020640
510k NumberK020640
Device Name:KSEA SCB MEDIA CONTROL
ClassificationLight, Surgical, Accessories
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentJames A Lee
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City,  CA  90230 -7600
Product CodeFTA  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-27
Decision Date2002-05-28
Summary:summary

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