KSEA SIALOENDOSCOPES AND ACCESSORIES

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 Sialoendoscopes And Accessories.

Pre-market Notification Details

Device IDK012527
510k NumberK012527
Device Name:KSEA SIALOENDOSCOPES AND ACCESSORIES
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentJames A Lee
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-06
Decision Date2001-11-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551196502 K012527 000

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