KSEA CMOS Camera System (C-cam)

Laparoscope, General & Plastic Surgery

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 Cmos Camera System (c-cam).

Pre-market Notification Details

Device IDK143640
510k NumberK143640
Device Name:KSEA CMOS Camera System (C-cam)
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo,  CA  90245
ContactSusie S Chen
CorrespondentWinkie Wong
KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo,  CA  90245
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-22
Decision Date2015-09-17
Summary:summary

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